41 results on '"Bogdanet, D"'
Search Results
2. Plasma glycated CD59 (gCD59), a novel biomarker for the diagnosis, management and follow up of women with Gestational Diabetes (GDM) – protocol for prospective cohort study
- Author
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Bogdanet, D., O’Shea, PM., Halperin, J., and Dunne, F.
- Published
- 2020
- Full Text
- View/download PDF
3. Endocrinopathies and renal outcomes in lithium therapy: impact of lithium toxicity
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Dineen, R, Bogdanet, D, Thompson, D, Thompson, C J, Behan, L A, McKay, A P, Boran, G, Wall, C, Gibney, J, O’Keane, V, and Sherlock, M
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- 2017
- Full Text
- View/download PDF
4. A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study.
- Author
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Kgosidialwa O., Bogdanet D., Egan A.M., O'Shea P.M., Newman C., Griffin T.P., McDonagh C., O'Shea C., Carmody L., Cooray S.D., Anastasiou E., Wender-Ozegowska E., Clarson C., Spadola A., Alvarado F., Noctor E., Dempsey E., Napoli A., Crowther C., Galjaard S., Loeken M.R., Maresh M.J.A., Gillespie P., de Valk H., Agostini A., Biesty L., Devane D., Dunne F., Kgosidialwa O., Bogdanet D., Egan A.M., O'Shea P.M., Newman C., Griffin T.P., McDonagh C., O'Shea C., Carmody L., Cooray S.D., Anastasiou E., Wender-Ozegowska E., Clarson C., Spadola A., Alvarado F., Noctor E., Dempsey E., Napoli A., Crowther C., Galjaard S., Loeken M.R., Maresh M.J.A., Gillespie P., de Valk H., Agostini A., Biesty L., Devane D., and Dunne F.
- Abstract
Objective: To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM). Design(s): A consensus developmental study. Setting(s): International. Population: Two hundred and five stakeholders completed the first round. Method(s): The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three-round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS. Main Outcome Measure(s): All outcomes were extracted from the literature. Result(s): We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester-specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy-induced hypertension, pre-eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death. Conclusion(s): This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM. Tweetable abstract: 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diab
- Published
- 2021
5. A core outcome set for studies of gestational diabetes mellitus prevention and treatment.
- Author
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van Poppel M.N.M., Thangaratinam S., Dunne F.P., Devane D., Biesty L.M., Crowther C., Egan A.M., Bogdanet D., Griffin T.P., Kgosidialwa O., Cervar-Zivkovic M., Dempsey E., Allotey J., Alvarado F., Clarson C., Cooray S.D., de Valk H.W., Galjaard S., Loeken M.R., Maresh M.J.A., Napoli A., O'Shea P.M., Wender-Ozegowska E., van Poppel M.N.M., Thangaratinam S., Dunne F.P., Devane D., Biesty L.M., Crowther C., Egan A.M., Bogdanet D., Griffin T.P., Kgosidialwa O., Cervar-Zivkovic M., Dempsey E., Allotey J., Alvarado F., Clarson C., Cooray S.D., de Valk H.W., Galjaard S., Loeken M.R., Maresh M.J.A., Napoli A., O'Shea P.M., and Wender-Ozegowska E.
- Abstract
Aims/hypothesis: The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). Method(s): We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. Result(s): Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). Conclusions/interpretation: This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. Trial registration: This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (
- Published
- 2020
6. A core outcome set for studies of gestational diabetes mellitus prevention and treatment
- Author
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Egan, A.M. (Aoife M.), Bogdanet, D. (Delia), Griffin, T.P. (Tomás P.), Kgosidialwa, O. (Oratile), Cervar-Zivkovic, M. (Mila), Dempsey, E. (Eugene), Allotey, J. (John), Alvarado, F. (Fernanda), Clarson, C. (Cheril), Cooray, S.D. (Shamil D.), Valk, H.W. (Harold) de, Galjaard, S. (Sander), Loeken, M.R. (Mary R.), Maresh, M.J.A. (Michael J. A.), Napoli, A. (Angela), O’Shea, P.M. (Paula M.), Wender-Ozegowska, E. (Ewa), Poppel, M.N. (Mireille) van, Thangaratinam, S. (Shakila), Crowther, C. (Caroline), Biesty, L.M. (Linda M.), Devane, D. (Declan), Dunne, F. (Fidelma), Egan, A.M. (Aoife M.), Bogdanet, D. (Delia), Griffin, T.P. (Tomás P.), Kgosidialwa, O. (Oratile), Cervar-Zivkovic, M. (Mila), Dempsey, E. (Eugene), Allotey, J. (John), Alvarado, F. (Fernanda), Clarson, C. (Cheril), Cooray, S.D. (Shamil D.), Valk, H.W. (Harold) de, Galjaard, S. (Sander), Loeken, M.R. (Mary R.), Maresh, M.J.A. (Michael J. A.), Napoli, A. (Angela), O’Shea, P.M. (Paula M.), Wender-Ozegowska, E. (Ewa), Poppel, M.N. (Mireille) van, Thangaratinam, S. (Shakila), Crowther, C. (Caroline), Biesty, L.M. (Linda M.), Devane, D. (Declan), and Dunne, F. (Fidelma)
- Abstract
Aims/hypothesis: The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). Methods: We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. Results: Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). Conclusions/interpretation: This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. Trial registration: This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COME
- Published
- 2020
- Full Text
- View/download PDF
7. A core outcome set for studies of gestational diabetes mellitus prevention and treatment
- Author
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Egan, AM, Bogdanet, D, Griffin, TP, Kgosidialwa, O, Cervar-Zivkovic, M, Dempsey, E, Allotey, J, Alvarado, F, Clarson, C, Cooray, SD, de Valk, HW, Galjaard, Sander, Loeken, MR, Maresh, MJA, Napoli, A, O’Shea, PM, Wender-Ozegowska, E, van Poppel, MN, Thangaratinam, S, Crowther, C, Biesty, LM, Devane, D, Dunne, FP, Egan, AM, Bogdanet, D, Griffin, TP, Kgosidialwa, O, Cervar-Zivkovic, M, Dempsey, E, Allotey, J, Alvarado, F, Clarson, C, Cooray, SD, de Valk, HW, Galjaard, Sander, Loeken, MR, Maresh, MJA, Napoli, A, O’Shea, PM, Wender-Ozegowska, E, van Poppel, MN, Thangaratinam, S, Crowther, C, Biesty, LM, Devane, D, and Dunne, FP
- Published
- 2020
8. Early gestational diabetes mellitus (GDM) is associated with worse pregnancy outcomes compared with GDM diagnosed at 24–28 weeks gestation despite early treatment
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Mustafa, M, primary, Bogdanet, D, additional, Khattak, A, additional, Carmody, L A, additional, Kirwan, B, additional, Gaffney, G, additional, O’Shea, P M, additional, and Dunne, F, additional
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- 2020
- Full Text
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9. Follow-up at 1 year and beyond of women with gestational diabetes treated with insulin and/or oral glucose-lowering agents: a core outcome set using a Delphi survey
- Author
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Bogdanet, D. (Delia), Reddin, C. (Catriona), Macken, E. (Esther), Griffin, T.P. (Tomas P.), Fhelelboom, N. (Narjes), Biesty, L. (Linda), Thangaratinam, S. (Shakila), Dempsey, E. (Eugene), Crowther, C. (Caroline), Galjaard, S. (Sander), Maresh, M. (Michael), Loeken, M.R. (Mary R.), Napoli, A. (Angela), Anastasiou, E. (Eleni), Noctor, E. (Eoin), Valk, H.W. (Harold) de, Poppel, M.N. (Mireille) van, Agostini, A. (Andrea), Clarson, C. (Cheril), Egan, A.M. (Aoife M.), O’Shea, P.M. (Paula M.), Devane, D. (Declan), Dunne, F. (Fidelma), Bogdanet, D. (Delia), Reddin, C. (Catriona), Macken, E. (Esther), Griffin, T.P. (Tomas P.), Fhelelboom, N. (Narjes), Biesty, L. (Linda), Thangaratinam, S. (Shakila), Dempsey, E. (Eugene), Crowther, C. (Caroline), Galjaard, S. (Sander), Maresh, M. (Michael), Loeken, M.R. (Mary R.), Napoli, A. (Angela), Anastasiou, E. (Eleni), Noctor, E. (Eoin), Valk, H.W. (Harold) de, Poppel, M.N. (Mireille) van, Agostini, A. (Andrea), Clarson, C. (Cheril), Egan, A.M. (Aoife M.), O’Shea, P.M. (Paula M.), Devane, D. (Declan), and Dunne, F. (Fidelma)
- Abstract
Aims/hypothesis: Gestational diabetes mellitus (GDM) is linked with a higher lifetime risk for the development of impaired fasting glucose, impaired glucose tolerance, type 2 diabetes, the metabolic syndrome, cardiovascular disease, postpartum depression and tumours. Despite this, there is no consistency in the long-term follow-up of women with a previous diagnosis of GDM. Further, the outcomes selected and reported in the research involving this population are heterogeneous and lack standardisation. This amplifies the risk of reporting bias and diminishes the likelihood of significant comparisons between studies. The
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- 2019
- Full Text
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10. Follow-up at 1 year and beyond of women with gestational diabetes treated with insulin and/or oral glucose-lowering agents: a core outcome set using a Delphi survey
- Author
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Bogdanet, D, Reddin, C, Macken, E, Griffin, TP, Fhelelboom, N, Biesty, L, Thangaratinam, S, Dempsey, E, Crowther, C, Galjaard, Sander, Maresh, M, Loeken, MR, Napoli, A, Anastasiou, E, Noctor, E, de Valk, HW, van Poppel, MN, Agostini, A, Clarson, C, Egan, AM, O'Shea, PM, Devane, D, Dunne, FP, Bogdanet, D, Reddin, C, Macken, E, Griffin, TP, Fhelelboom, N, Biesty, L, Thangaratinam, S, Dempsey, E, Crowther, C, Galjaard, Sander, Maresh, M, Loeken, MR, Napoli, A, Anastasiou, E, Noctor, E, de Valk, HW, van Poppel, MN, Agostini, A, Clarson, C, Egan, AM, O'Shea, PM, Devane, D, and Dunne, FP
- Published
- 2019
11. A systematic review on outcome reporting in randomised controlled trials assessing treatment interventions in pregnant women with pregestational diabetes.
- Author
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Kgosidialwa, O, Bogdanet, D, Egan, A, Newman, C, O'Shea, PM, Biesty, L, McDonagh, C, O'Shea, C, Devane, D, and Dunne, F
- Subjects
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PREGNANT women , *RANDOMIZED controlled trials , *DIABETES , *DRUG therapy , *PREGNANCY outcomes - Abstract
Background: Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes. Studies assessing interventions to improve maternal and infant outcomes have increased exponentially over recent years. Several outcomes in this field of maternal diabetes are rare, making it difficult to synthesise evidence. Objectives: To collect outcomes reported in studies assessing treatment interventions in pregnant women with PGDM. Search strategy: CENTRAL, Web of Science, Medline, CINAHL, Embase and ClinicalTrials.gov from their inception until 27 January 2020. Selection criteria: Any randomised controlled trial assessing treatment interventions in pregnant women with PGDM reported in English. Data collection and analysis: Two independent reviewers assessed the suitability of articles and retrieved the data. Outcomes extracted from the literature were broadly categorised into maternal, fetal/infant or other outcomes by the study advisory group. Main results: Sixty‐seven of the 1475 studies identified fulfilled the inclusion criteria. The median number of outcomes reported per study was 15 (range 1–46). The majority of studies were from North America and Europe. Insulin and metformin were the most commonly investigated pharmacological interventions. Glucose monitoring was the most assessed technological intervention. In all, 131 unique outcomes were extracted: maternal (n = 69), fetal/infant (n = 61) and other (n = 1). Conclusions: Outcome reporting in treatment interventions trials of pregnant women with PGDM is varied, making it difficult to synthesise evidence, especially for rare outcomes. Systems are needed to standardise outcome reporting in future clinical trials and so facilitate evidence synthesis in this area of maternal diabetes. Registration: The systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO) database (Registration number CRD42020173549). Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy. Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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12. A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study.
- Author
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Kgosidialwa, O, Bogdanet, D, Egan, AM, O'Shea, PM, Newman, C, Griffin, TP, McDonagh, C, O'Shea, C, Carmody, L, Cooray, SD, Anastasiou, E, Wender‐Ozegowska, E, Clarson, C, Spadola, A, Alvarado, F, Noctor, E, Dempsey, E, Napoli, A, Crowther, C, and Galjaard, S
- Abstract
Objective: To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM). Design: A consensus developmental study. Setting: International. Population: Two hundred and five stakeholders completed the first round. Methods: The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three‐round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS. Main outcome measures: All outcomes were extracted from the literature. Results: We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester‐specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy‐induced hypertension, pre‐eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death. Conclusions: This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM. 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy. 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy. [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF
13. Early gestational diabetes mellitus (GDM) is associated with worse pregnancy outcomes compared with GDM diagnosed at 24–28 weeks gestation despite early treatment.
- Author
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Mustafa, M, Bogdanet, D, Khattak, A, Carmody, L A, Kirwan, B, Gaffney, G, O'Shea, P M, and Dunne, F
- Subjects
- *
PREGNANCY outcomes , *GESTATIONAL diabetes , *PREGNANCY , *PREECLAMPSIA , *NEONATAL intensive care - Abstract
Background Gestational diabetes mellitus (GDM) is associated+ with adverse pregnancy outcomes compared with women with normal glucose tolerance in pregnancy. The WHO recommends screening at 24–28 weeks gestation for GDM. Women who are diagnosed before 24–28 weeks gestation have a longer intervention period which may impact positively on pregnancy outcomes. Aim This study aimed to examine pregnancy outcomes of women with GDM diagnosed <24 weeks gestation compared with those diagnosed at 24–28 weeks in a large Irish cohort. Methods A retrospective cohort study of 1471 pregnancies in women with GDM diagnosed using IADPSG criteria between September 2012 and April 2016 was conducted. At GDM diagnosis, women were classified as early GDM <24 weeks or standard GDM 24–28 weeks gestation. Results Women with early GDM had a significantly greater risk of pregnancy-induced hypertension (12.4% vs. 5.3%; P < 0.05), post-partum haemorrhage (8.7% vs. 2.4%; P < 0.05) and post-partum glucose abnormalities (32% vs. 15.6%; P < 0.05). Their offspring had a greater risk of pre-maturity (10.9% vs. 6.6%; P < 0.05), stillbirth (1.4% vs. 0.5%; P < 0.05), large for gestational age (19.1% vs. 13.4% P < 0.05) and need neonatal intensive care (30.7% vs. 22.1%; P < 0.05) compared with offspring of women with standard GDM. Rates of C-section and pre-maturity were still higher in the early GDM group when the two groups where compared based on their post-natal OGTT. Conclusion Early GDM women and their offspring are at greater risk of an adverse pregnancy outcome compared with those diagnosed at 24–28 weeks. In view of the abnormal post-natal glucose findings, early GDM may reflect a more advanced state in diabetes pathogenesis. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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14. Abnormal aldosterone/renin ratio is common in patients of African compared to European origin, is associated with hypokalaemia, and left ventricular hypertrophy, but is rarely associated with abnormal adrenal imaging characteristics
- Author
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Ahmed, KS, primary, Bogdanet, D, additional, Heshe, S, additional, Boran, G, additional, Behan, LA, additional, Sherlock, M, additional, and Gibney, J, additional
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- 2017
- Full Text
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15. ATLANTIC DIP: Insulin Therapy for women with IADPSG-diagnosed Gestational Diabetes Mellitus. Does it work?
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Bogdanet, D, primary, Egan, AM, additional, Reddin, C, additional, Kgosidialwa, O, additional, Kirwan, B, additional, Carmody, L, additional, and Dunne, FP, additional
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- 2016
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16. A Rare Case of Infertility: SRY Positive 46, XX Testicular Disorder of Sexual Differentiation.
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Bogdanet, D., Griffin, T. P., and Bell, M.
- Published
- 2020
17. Alcohol consumption and heart failure: a dose-response meta-analysis.
- Author
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Wong B, Ryan C, Fagbamigbe A, Bray JJ, McNamee B, Niranjan V, Zhou S, Bogdanet D, Reddin C, McDonald K, and Ledwidge M
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- Humans, Systematic Reviews as Topic, Ventricular Dysfunction, Left, Heart Failure, Alcohol Drinking adverse effects, Stroke Volume, Disease Progression
- Abstract
Objectives: This is a protocol for a Cochrane Review (prototype). The objectives are as follows: Main objective To assess the effects of alcohol consumption on the progression to symptomatic (stage C) heart failure in people at risk for heart failure (stage A) or in people with pre-heart failure (stage B). Secondary objectives To assess the effects of alcohol consumption on progression of left ventricular dysfunction in people with stage A or stage B heart failure. We will assess the effect of alcohol consumption on the development of heart failure with reduced ejection fraction, mildly reduced ejection fraction, and preserved ejection fraction. We also aim to evaluate the effects of alcohol consumption on the development of symptomatic (stage C) heart failure over the short, medium and long term., (Copyright © 2024 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)
- Published
- 2024
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18. Early Metformin in Gestational Diabetes: A Randomized Clinical Trial.
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Dunne F, Newman C, Alvarez-Iglesias A, Ferguson J, Smyth A, Browne M, O'Shea P, Devane D, Gillespie P, Bogdanet D, Kgosidialwa O, Egan A, Finn Y, Gaffney G, Khattak A, O'Keeffe D, Liew A, and O'Donnell M
- Subjects
- Adult, Female, Humans, Infant, Newborn, Pregnancy, Birth Weight, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents adverse effects, Hypoglycemic Agents therapeutic use, Insulin administration & dosage, Insulin therapeutic use, Double-Blind Method, Diabetes, Gestational drug therapy, Metformin administration & dosage, Metformin adverse effects, Metformin therapeutic use
- Abstract
Importance: Gestational diabetes is a common complication of pregnancy and the optimal management is uncertain., Objective: To test whether early initiation of metformin reduces insulin initiation or improves fasting hyperglycemia at gestation weeks 32 or 38., Design, Setting, and Participants: Double-blind, placebo-controlled trial conducted in 2 centers in Ireland (one tertiary hospital and one smaller regional hospital). Participants were enrolled from June 2017 through September 2022 and followed up until 12 weeks' postpartum. Participants comprised 510 individuals (535 pregnancies) diagnosed with gestational diabetes based on World Health Organization 2013 criteria., Interventions: Randomized 1:1 to either placebo or metformin (maximum dose, 2500 mg) in addition to usual care., Main Outcomes and Measures: The primary outcome was a composite of insulin initiation or a fasting glucose level of 5.1 mmol/L or greater at gestation weeks 32 or 38., Results: Among 510 participants (mean age, 34.3 years), 535 pregnancies were randomized. The primary composite outcome was not significantly different between groups and occurred in 150 pregnancies (56.8%) in the metformin group and 167 pregnancies (63.7%) in the placebo group (between-group difference, -6.9% [95% CI, -15.1% to 1.4%]; relative risk, 0.89 [95% CI, 0.78-1.02]; P = .13). Of 6 prespecified secondary maternal outcomes, 3 favored the metformin group, including time to insulin initiation, self-reported capillary glycemic control, and gestational weight gain. Secondary neonatal outcomes differed by group, with smaller neonates (lower mean birth weights, a lower proportion weighing >4 kg, a lower proportion in the >90% percentile, and smaller crown-heel length) in the metformin group without differences in neonatal intensive care needs, respiratory distress requiring respiratory support, jaundice requiring phototherapy, major congenital anomalies, neonatal hypoglycemia, or proportion with 5-minute Apgar scores less than 7., Conclusion and Relevance: Early treatment with metformin was not superior to placebo for the composite primary outcome. Prespecified secondary outcome data support further investigation of metformin in larger clinical trials., Trial Registration: ClinicalTrials.gov Identifier: NCT02980276; EudraCT: 2016-001644-19.
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- 2023
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19. The utility of plasma glycated CD59 in predicting postpartum glucose intolerance: A prospective study of women diagnosed with GDM during a period of universal GDM screening.
- Author
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Bogdanet D, Castillo MT, Doheny H, Dervan L, Luque-Fernandez MA, Halperin J, O'Shea PM, and Dunne FP
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- Female, Pregnancy, Humans, Prospective Studies, Blood Glucose, Glucose Tolerance Test, Retrospective Studies, Postpartum Period, Biomarkers, CD59 Antigens, Diabetes, Gestational diagnosis, Glucose Intolerance diagnosis, Glucose Intolerance epidemiology
- Abstract
Aims: Gestational diabetes (GDM) is associated with the development of postpartum (PP) glucose intolerance. Plasma glycated CD59 (pGCD59) is an emerging biomarker for the detection of hyperglycaemia. The aim of this study was to assess the ability of PP pGCD59 to predict the development of PP GI as defined by the 2 h 75 g OGTT using the ADA criteria, in a cohort of women diagnosed with prior GDM in the index pregnancy using the 2 h 75 g OGTT at 24-28 weeks of gestation according to the World Health Organization (WHO) 2013 criteria., Methods: Of the 2017 pregnant women recruited prospectively 140 women with gestational diabetes had samples for pGCD59 taken PP at the time of the OGTT. The ability of pGCD59 to predict the results of the PP OGTT was assessed using nonparametric receiver operating characteristic (ROC) curves., Results: Women with PP glucose intolerance had significantly higher PP pGCD59 levels compared to women with normal glucose tolerance PP (3.8 vs. 2.7 SPU). PP pGCD59 identified women who developed glucose intolerance PP with an AUC of 0.80 (95% CI: 0.70-0.91). A PP pGCD59 cut-off value of 1.9 SPU generated a sensitivity of 100% (95% CI: 83.9-100), specificity of 16.9% (95% CI: 9.8-26.3), positive predictive value of 22.1% (95% CI: 21.0-22.6), and negative predictive value of 100% (95% CI: 87.4-100). PP fasting plasma glucose generated an AUC of 0.96 (95% CI: 0.89-0.99) for the identification of PP glucose intolerance., Conclusion: Our study found that PP pGCD9 may be a promising biomarker to identify women not requiring PP glucose intolerance screening using the traditional OGTT. While the diagnostic accuracy of pGCD59 is good, fasting plasma glucose remains a better test for the identification of PP glucose intolerance., (© 2023 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)
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- 2023
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20. The ability of pGCD59 to predict adverse pregnancy outcomes: a prospective study of non-diabetic pregnant women in Ireland.
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Bogdanet D, Castillo MT, Doheny H, Dervan L, Luque-Fernandez MA, Halperin JA, O'Shea PM, and Dunne FP
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- Infant, Newborn, Pregnancy, Female, Humans, Prospective Studies, Pregnant Women, Ireland, Pregnancy Outcome epidemiology, Birth Weight, Biomarkers, Diabetes, Gestational diagnosis, Diabetes, Gestational epidemiology
- Abstract
Aim: Even though most pregnancies are uneventful, occasionally complications do occur. Gestational diabetes is linked to an increased risk of adverse pregnancy outcomes. Early identification of women at risk of experiencing adverse outcomes, ideally through a single blood test, would facilitate early intervention. Plasma glycated CD59 (pGCD59) is an emerging biomarker which has shown promise in identifying hyperglycaemia during pregnancy and has been associated with the risk of delivering an LGA infant. The aim of this study was to explore the ability of the first- and second-trimester pGCD59 to predict adverse pregnancy outcomes., Methods: This was a prospective study of 378 pregnant women. Samples for pGCD59 were taken at the first antenatal visit and at the time of the 2 h 75 g OGTT (24-28 weeks of gestation). Adjusted receiver operating characteristic curves were used to evaluate the ability of pGCD59 to predict maternal and neonatal outcomes., Results: First-trimester pGCD59 levels were higher in women with gestational diabetes who delivered a macrosomic infant (4.2 ± 0.7 vs. 3.5 ± 1.0 SPU, p < 0.01) or an LGA infant (4.3 ± 0.3 vs. 3.6 ± 1.0 SPU, p = 0.01) compared to women with GDM that did not experience these outcomes. Second-trimester pGCD59 levels were higher in women that developed polyhydramnios (2.9 ± 0.4 vs. 2.5 ± 1.1 SPU, p = 0.03). First- and second-trimester pGCD59 predicted pregnancy-induced hypertension with good accuracy (AUC:0.85, 95%CI:0.78-0.91; AUC: 0.80, 95%CI: 0.73-0.88, respectively) and neonatal hypoglycaemia with fair to good accuracy (AUC:0.77, 95%CI: 0.54-0.99, AUC:0.81, 95%CI:0.62-0.99)., Conclusions: This study has shown that pGCD59 has the potential to predict adverse pregnancy outcomes. Prospective studies with a larger number of cases are necessary to fully explore and validate the potential of this emerging biomarker in predicting adverse pregnancy outcomes., (© 2022. The Author(s).)
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- 2023
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21. The Role of Early Pregnancy Maternal pGCD59 Levels in Predicting Neonatal Hypoglycemia-Subanalysis of the DALI Study.
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Bogdanet D, Luque-Fernandez MA, Toth-Castillo M, Desoye G, O'Shea PM, Dunne FP, and Halperin JA
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- Infant, Newborn, Infant, Female, Pregnancy, Humans, Blood Glucose metabolism, Glucose Tolerance Test, Biomarkers analysis, Diabetes, Gestational epidemiology, Hypoglycemia epidemiology, Infant, Newborn, Diseases, Fetal Diseases
- Abstract
Context: Neonatal hypoglycaemia (NH) is the most common metabolic problem in infants born of mothers with gestational diabetes. Plasma glycated CD59 (pGCD59) is an emerging biomarker that has shown potential in identifying women at risk of developing gestational diabetes. The aim of this study was to assess the association between early maternal levels of pGCD59 and NH., Objective: The aim of this study was to assess the association between early pregnancy maternal levels of plasma glycated CD59 (pGCD59) and neonatal hypoglycemia (NH)., Methods: This is an observational study of pregnant women with a prepregnancy body mass index (BMI) greater than or equal to 29 screened for eligibility to participate in the Vitamin D and Lifestyle Intervention for Gestational Diabetes (DALI) trial. This analysis included 399 pregnancies. Levels of pGCD59 were measured in fasting maternal samples taken at the time of a 75-g, 2-hour oral glucose tolerance test performed in early pregnancy (< 20 weeks). NH, the study outcome, was defined as a heel-prick capillary glucose level of less than 2.6 mmol/L within 48 hours of delivery., Results: We identified 30 infants with NH. Maternal levels of pGCD59 in early pregnancy were positively associated with the prevalence of NH (one-way analysis of variance, P < .001). The odds of NH were higher in infants from mothers in tertile 3 of pGCD59 levels compared to those from mothers in tertile 1 (odds ratio [OR]: 2.41; 95% CI, 1.03-5.63). However, this was attenuated when adjusted for maternal BMI (OR: 2.28; 95% CI, 0.96-5.43). The cross-validated area under the curve (AUC) was 0.64 (95% CI, 0.54-0.74), and adjusted for maternal BMI, age, and ethnicity, the AUC was 0.70 (95% CI, 0.56-0.78)., Conclusion: Although pGCD59 levels in early pregnancy in women with BMI greater than or equal to 29 are associated with NH, our results indicate that this biomarker by itself is only a fair predictor of NH., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society.)
- Published
- 2022
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22. Reference intervals for clinical biochemistry and haematology tests during normal pregnancy.
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Groenendijk W, Bogdanet D, Dervan L, Finn O, Islam MN, Doheny H, Griffin TP, Blake L, Lyons M, Kilcooley M, Krawczyk J, Gilmore R, Griffin DG, Gaffney G, Dunne FP, and O'Shea PM
- Subjects
- Adult, Female, Pregnancy, Humans, Infant, Adolescent, Prospective Studies, Retrospective Studies, Reference Values, Hematologic Tests, Hematology
- Abstract
Background: Pregnancy induces physiological changes which affect biochemical and haematological parameters. As the significance of laboratory test results change throughout pregnancy, the reference interval (RI) or key result interpretive guide should be specific to pregnancy. This study sought to establish trimester-specific-RIs for routine biochemical and haematological tests in healthy white European women with singleton pregnancies with comparison to RIs for non-pregnant European adults., Methods: A retrospective analysis of a prospective longitudinal single-centre study of healthy pregnant women conducted between November 2018 and December 2020 in a tertiary academic hospital with approximately 3000 births annually. Inclusion criteria: signed informed consent, age ≥18 years, white European, body mass index (BMI) <25 kg/m2, blood pressure <140/90mmHg, non-smoker, no previous pathology or gestational diabetes. Trimester defined as T1: up to 13 weeks + 6 days, T2: 14-27 weeks + 6 days and T3: ≥28-41 weeks + 6 days. Baseline demographics, anthropometric and laboratory measurements were recorded. In total, 31 biochemical and 10 haematological ISO15189:2012 accredited tests were measured using Roche Cobas® and Sysmex XN-9100™ analysers, respectively. RIs were established according to the International Federation of Clinical Chemistry (IFCC) recommended method., Results: Apparently healthy pregnant women ( n = 124) with bio-banked serum samples in each trimester were recruited. At the booking visit, 49.2% ( n = 61) of participants were nulliparous, with median age of 34.4 (IQR: 31.3-37.3) years, gestational age of 89 (IQR: 84-93) days, BMI of 22.5 (IQR: 21.0-23.7) kg/m
2 and systolic and diastolic blood pressure of 116 (110-125) mmHg and 67 (61-75) mmHg, respectively., Conclusions: Normative trimester-specific biological intervals for routinely requested biochemical and haematological medical laboratory tests were established. These RIs will be invaluable to result interpretation and the management of pregnant women.- Published
- 2022
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23. The utility of first trimester plasma glycated CD59 (pGCD59) in predicting gestational diabetes mellitus: A prospective study of non-diabetic pregnant women in Ireland.
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Bogdanet D, Toth Castillo M, Doheny H, Dervan L, Angel Luque-Fernandez M, Halperin J, O'Shea PM, and Dunne FP
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- Blood Glucose, Body Mass Index, CD59 Antigens, Female, Humans, Ireland, Pregnancy, Pregnancy Trimester, First, Pregnant Women, Prospective Studies, Diabetes, Gestational diagnosis
- Abstract
Aims: To evaluate the ability of first trimester plasma glycated CD59 (pGCD59) to predict gestational diabetes mellitus (GDM) at 24-28 weeks of gestation., Methods: Prospectively, in 378 pregnant women, GDM was diagnosed using the one step 2 h 75 g oral glucose tolerance test adjudicated by the World Health Organisation (WHO) 2013 criteria. The ability of pGCD59 to predict GDM was assessed using receiver operating characteristic (ROC) curves adjusted for maternal age, body mass index (BMI), maternal ethnicity, parity, previous GDM, family history of diabetes mellitus and week of gestation at time of pGCD59 sampling., Results: pGCD59 generated an adjusted area under the curve (AUC) of (a) 0.63 (95 %CI:0.56-0.70, p < 0.001) for predicting GDM, and (b) 0.71 (95 %CI:0.62-0.79, p < 0.001 for GDM diagnosed with a fasting plasma glucose (FPG) ≥ 5.1 mmol/L. Sensitivity analysis of BMI subgroups showed that pGCD59 generated the highest AUC in the 35 kg/m
2 ≤ BMI < 40 kg/m2 (AUC:0.85, 95 %CI:0.70-0.98) and BMI ≥ 40 kg/m2 (AUC:0.88, 95 %CI:0.63-0.99) categories., Conclusions: Early in pregnancy, pGCD59 may be a good predictor of GDM in women with a high BMI and a fair predictor of GDM diagnosed by an elevated FPG independent of BMI., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JAH has a financial interest in Mellitus LLC. Mellitus has licensed intellectual property for the technology used in this research and in developing diagnostic tools for diabetes. The interests of J.A.H. are reviewed and are managed by Brigham and Women's Hospital and Partners HealthCare in accordance with their conflict-of-interest policies. Reagents and laboratory analysis for pGCD59 were provided by Prof Jose Halperin., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)- Published
- 2022
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24. The Diagnostic Accuracy of Second Trimester Plasma Glycated CD59 (pGCD59) to Identify Women with Gestational Diabetes Mellitus Based on the 75 g OGTT Using the WHO Criteria: A Prospective Study of Non-Diabetic Pregnant Women in Ireland.
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Bogdanet D, Toth Castillo M, Doheny H, Dervan L, Luque-Fernandez MA, Halperin JA, O'Shea PM, and Dunne FP
- Abstract
The aim of this study was to evaluate the ability of second trimester plasma glycated CD59 (pGCD59), a novel biomarker, to predict the results of the 2 h 75 g oral glucose tolerance test at 24−28 weeks of gestation, employing the 2013 World Health Organisation criteria. This was a prospective study of 378 pregnant women. The ability of pGCD59 to predict gestational diabetes (GDM) was assessed using adjusted ROC curves for maternal age, BMI, maternal ethnicity, parity, previous GDM, and family history of diabetes. The pGCD59 levels were significantly higher in women with GDM compared to women with normal glucose tolerance (p = 0.003). The pGCD59 generated an adjusted AUC for identifying GDM cases of 0.65 (95%CI: 0.58−0.71, p < 0.001). The pGCD59 predicted GDM status diagnosed by a fasting glucose value of 5.1 mmol/L with an adjusted AUC of 0.74 (95%CI: 0.65−0.81, p < 0.001). Analysis of BMI subgroups determined that pGCD59 generated the highest AUC in the 35 kg/m2 ≤ BMI < 40 kg/m2 (AUC: 0.84 95%CI: 0.69−0.98) and BMI ≥ 40 kg/m2 (AUC: 0.96 95%CI: 0.86−0.99) categories. This study found that second trimester pGCD59 is a fair predictor of GDM status diagnosed by elevated fasting glucose independent of BMI and an excellent predictor of GDM in subjects with a very high BMI.
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- 2022
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25. Patient-reported outcomes (PROs) in randomised controlled trials in diabetes and pregnancy: protocol for a systematic review.
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Newman C, Kgosidialwa O, Dervan L, Bogdanet D, Egan AM, Biesty L, Devane D, O'Shea PM, and Dunne F
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- Checklist, Female, Humans, Pregnancy, Randomized Controlled Trials as Topic, Research Design, Systematic Reviews as Topic, Diabetes Mellitus, Patient Reported Outcome Measures
- Abstract
Introduction: Diabetes mellitus is the most common metabolic complication of pregnancy and its prevalence worldwide is rising. The number of randomised controlled trials (RCTs) being conducted in people with diabetes is also increasing. Many studies preferentially publish findings on clinical endpoints and do not report patient-reported outcomes (PROs). In studies that do include PROs, PRO reporting is often of poor quality., Methods: We will conduct this systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Using a combination of medical subject headings and keywords (combined using Boolean operators), we will search web-based databases (PubMed, Cochrane and EMBASE) for RCTs published in English between 2013 and 2021. Two reviewers will review titles and abstracts. We will review the full texts of any relevant abstracts and extract the following data: date of publication or recruitment period, journal of publication, country of study, multicentre or single centre, population and number of participants, type of intervention, frequency of PRO assessment and type of PRO (or PRO measurement) used. We will also record if the PRO was a primary, secondary or exploratory outcome. We will exclude reviews, observational studies, unpublished data for example, conference abstracts and trial protocols. Any published RCT that includes data on a PRO as a primary or secondary outcome will then be compared against the Consolidated Standards of Reporting Trials-Patient-Reported Outcome extension checklist, a structured and approved framework for the publication of results of PROs., Ethics and Dissemination: Ethical approval to conduct this study was obtained from the ethics committee at Galway University Hospitals on 24 March 2021 (CA 2592). We aim to publish our findings in a peer-reviewed journal and present our findings at national and international conferences., Systematic Review Registration: This systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO). Registration number CRD42021234917., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2021
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26. Atlantic DIP: is weight gain less than that recommended by IOM safe in obese women with gestational diabetes mellitus?
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Bogdanet D, Mustafa M, Khattak A, Shea PMO, and Dunne FP
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- Adult, Body Mass Index, Diabetes, Gestational drug therapy, Female, Humans, Ireland, Obesity therapy, Pregnancy, Retrospective Studies, United States, Diabetes, Gestational epidemiology, Gestational Weight Gain, Obesity epidemiology, Pregnancy Outcome epidemiology
- Abstract
Background/objectives: The Institute of Medicine (IOM) recommends gestational weight gain (GWG) of 5-9 kg in women with a body mass index (BMI) ≥ 30 kg/m
2 . Debate continues as to whether GWG less than that recommended is safe in women with gestational diabetes mellitus (GDM). The study objective was to examine maternal and infant outcomes for obese women with GDM who lost weight or gained 0-5 kg during pregnancy., Subjects/methods: A 7-year retrospective cohort study of pregnancy outcomes for obese women with GDM recorded in the Atlantic Diabetes in Pregnancy database was conducted. We examined pregnancy outcomes for mothers with GDM and a BMI ≥ 30 who either lost weight or gained 0-5 kg (Group 1, n = 237) and women who gained 5-9 kg (Group 2, n = 77). We further divided groups 1 and 2 into women treated by diet only (GDM-D) (n = 120) and those requiring additional treatment with insulin (GDM-I) (n = 194)., Results: GDM-D women in Group 1 were more likely to deliver earlier (38.9 vs 39.8 weeks, p < 0.01), to develop pregnancy induced hypertension (PIH) (15.4% v 0%; p = 0.02) or have a post-partum haemorrhage (PPH) (13.2% vs 0, p = 0.03) compared to women in Group 2. Rates of prematurity were higher in group 1 vs 2 (14.3% vs 0%, p = 0.03). However, further logistic regression analysis adjusted for smoking status, family history of diabetes, ethnicity and age determined no significant difference in maternal or infant outcomes for women in Group 1 compared to those in Group 2., Conclusion: In our population, weight gain less than IOM guideline appears safe and is not associated with any further increase in adverse outcomes. However, validation through a prospective study with a larger obese GDM cohort is required before the findings presented here could be recommended for routine clinical use.- Published
- 2021
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27. Emerging Protein Biomarkers for the Diagnosis or Prediction of Gestational Diabetes-A Scoping Review.
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Bogdanet D, Reddin C, Murphy D, Doheny HC, Halperin JA, Dunne F, and O'Shea PM
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Introduction: Gestational diabetes (GDM), defined as hyperglycemia with onset or initial recognition during pregnancy, has a rising prevalence paralleling the rise in type 2 diabetes (T2DM) and obesity. GDM is associated with short-term and long-term consequences for both mother and child. Therefore, it is crucial we efficiently identify all cases and initiate early treatment, reducing fetal exposure to hyperglycemia and reducing GDM-related adverse pregnancy outcomes. For this reason, GDM screening is recommended as part of routine pregnancy care. The current screening method, the oral glucose tolerance test (OGTT), is a lengthy, cumbersome and inconvenient test with poor reproducibility. Newer biomarkers that do not necessitate a fasting sample are needed for the prompt diagnosis of GDM. The aim of this scoping review is to highlight and describe emerging protein biomarkers that fulfill these requirements for the diagnosis of GDM. Materials and Methods: This scoping review was conducted according to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines for scoping reviews using Cochrane Central Register of Controlled Trials (CENTRAL), the Cumulative Index to Nursing & Allied Health Literature (CINAHL), PubMed, Embase and Web of Science with a double screening and extraction process. The search included all articles published in the literature to July 2020. Results: Of the 3519 original database citations identified, 385 were eligible for full-text review. Of these, 332 (86.2%) were included in the scoping review providing a total of 589 biomarkers studied in relation to GDM diagnosis. Given the high number of biomarkers identified, three post hoc criteria were introduced to reduce the items set for discussion: we chose only protein biomarkers with at least five citations in the articles identified by our search and published in the years 2017-2020. When applied, these criteria identified a total of 15 biomarkers, which went forward for review and discussion. Conclusions: This review details protein biomarkers that have been studied to find a suitable test for GDM diagnosis with the potential to replace the OGTT used in current GDM screening protocols. Ongoing research efforts will continue to identify more accurate and practical biomarkers to take GDM screening and diagnosis into the 21st century.
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- 2021
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28. Developing a core outcome set for the treatment of pregnant women with pregestational diabetes-a study protocol.
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Kgosidialwa O, Bogdanet D, Egan A, O'Shea PM, Biesty L, Devane D, and Dunne F
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- Cesarean Section, Delphi Technique, Female, Humans, Infant, Newborn, Outcome Assessment, Health Care, Pregnancy, Randomized Controlled Trials as Topic, Research Design, Systematic Reviews as Topic, Treatment Outcome, Diabetes Mellitus, Pregnant Women
- Abstract
Background: Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes including increased rates of caesarean section birth, macrosomia, congenital malformation, prematurity, admission to the neonatal intensive care unit and stillbirth. As a result, there has been an increase in interventions to improve outcomes in both mother and infant. To date, meaningful comparisons between these studies are limited due to heterogeneity in outcome selection and reporting. The aim of this study is to develop a core outcome set (COS) for randomised controlled trials evaluating the effectiveness of interventions for the treatment of pregnant women with PGDM., Methods: The study consists of three steps. The first step is a systematic review of the literature to assess outcomes reported in randomised controlled trials assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. The second step is a three round, online Delphi survey to prioritise these outcomes. In this step, stakeholders (including women with PGDM, healthcare workers, researchers and policymakers) will be asked to rank the importance of outcomes for inclusion in the COS using a 9-point Likert type scale. Outcomes that meet the inclusion criteria after completion of the Delphi surveys will be brought to the consensus meeting. The consensus meeting will be the third and final step, where the COS will be finalised. The consensus meeting will include members from each stakeholder group., Discussion: This paper describes the process used to develop a COS for the reporting of studies evaluating the effectiveness of interventions in pregnant women with PGDM. The COS will enable greater comparison between and information synthesis across RCTs in the treatment of PGDM. In addition, this COS will also help improve trial reporting and minimise research waste by prioritising the collection and reporting of outcomes that matter to all relevant stakeholder groups., Trial Registration: This COS has been registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative ( http://www.comet-initiative.org/studies/details/1425 ) on the 4th of November 2019. The systematic review component of this study has also been registered with the International Prospective Register of Systematic Reviews (PROSPERO) ( https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020173549 ).
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- 2020
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29. Core Outcome Sets for Studies of Diabetes in Pregnancy: A Review.
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Egan AM, Bogdanet D, Biesty L, Kgosidialwa O, McDonagh C, O'Shea C, O'Shea PM, Devane D, and Dunne FP
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- Consensus, Delphi Technique, Evidence-Based Practice methods, Evidence-Based Practice standards, Female, Humans, Practice Patterns, Physicians' standards, Pregnancy, Prognosis, Research Design, Translational Research, Biomedical methods, Translational Research, Biomedical standards, Treatment Outcome, Diabetes, Gestational diagnosis, Diabetes, Gestational therapy, Diagnostic Techniques, Endocrine standards, Endpoint Determination methods, Endpoint Determination standards
- Abstract
Core Outcome Sets (COS) contain an agreed minimum set of outcomes to be measured and reported in all studies in a specific area, with the objective of standardizing outcome reporting. COS may minimize research waste by identifying outcomes important to key stakeholders, allowing for improved evidence synthesis, and facilitating translation of research findings to clinical practice. Over the past 5 years, there has been significant progress in developing COS relevant to studies of diabetes in pregnancy. This review summarizes work in this area, reviews the role of patient and public involvement in COS development, and suggests areas for future research., (© 2020 by the American Diabetes Association.)
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- 2020
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30. The Oral Glucose Tolerance Test-Is It Time for a Change?-A Literature Review with an Emphasis on Pregnancy.
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Bogdanet D, O'Shea P, Lyons C, Shafat A, and Dunne F
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Globally, gestational diabetes (GDM) is increasing at an alarming rate. This increase is linked to the rise in obesity rates among women of reproductive age. GDM poses a major global health problem due to the related micro- and macro-vascular complications of subsequent Type 2 diabetes and the impact on the future health of generations through the long-term impact of GDM on both mothers and their infants. Therefore, correctly identifying subjects as having GDM is of utmost importance. The oral glucose tolerance test (OGTT) has been the mainstay for diagnosing gestational diabetes for decades. However, this test is deeply flawed. In this review, we explore a history of the OGTT, its reproducibility and the many factors that can impact its results with an emphasis on pregnancy.
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- 2020
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31. Biallelic CYP24A1 variants presenting during pregnancy: clinical and biochemical phenotypes.
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Griffin TP, Joyce CM, Alkanderi S, Blake LM, O'Keeffe DT, Bogdanet D, Islam MN, Dennedy MC, Gillan JE, Morrison JJ, O'Brien T, Sayer JA, Bell M, and O'Shea PM
- Abstract
Introduction: Inactivating mutations in CYP24A1, encoding vitamin D-24-hydroxylase, can lead to an accumulation of active vitamin D metabolites and consequent hypercalcaemia. Patient (infantile and adult) presentation is varied and includes mild-severe hypercalcaemia, hypercalciuria, nephrocalcinosis and nephrolithiasis. This study aimed to characterize the clinical and biochemical phenotypes of a family with two CYP24A1 missense variants., Methods: The proband and seven family members underwent detailed clinical and biochemical evaluation. Laboratory measurements included serum calcium, intact parathyroid hormone (iPTH), vitamin D metabolites and urine calcium and creatinine., Results: The proband presented during the second trimester of a planned pregnancy with flu-like symptoms. Laboratory tests showed elevated adjusted calcium of 3.27 (upper reference limit (URL: 2.30) mmol/L), suppressed iPTH (<6 ng/L), elevated 25(OH)D (264 (URL: 55) nmol/L) and elevated 1,25(OH)D (293 (URL: <280) pmol/L). Ionized calcium was 1.55 (URL: 1.28) mmol/L. Sanger sequencing revealed two heterozygous missense variants in the CYP24A1: p.(Arg439Cys), R439C and p.(Trp275Arg), W275R. The proband's brother and sister had the same genotype. The brother had intermittent hypercalcaemia and hypervitaminosis D. Only the sister had a history of nephrolithiasis. The proband's daughter and two nephews were heterozygous for the R439C variant. The proband and her brother frequently had elevated 25(OH)D:24,25(OH)2D ratios (>50) during follow-up., Conclusions: W275R is a new pathogenic CYP24A1 mutation in compound heterozygotic form with R439C in this family.
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- 2020
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32. A core outcome set for studies of gestational diabetes mellitus prevention and treatment.
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Egan AM, Bogdanet D, Griffin TP, Kgosidialwa O, Cervar-Zivkovic M, Dempsey E, Allotey J, Alvarado F, Clarson C, Cooray SD, de Valk HW, Galjaard S, Loeken MR, Maresh MJA, Napoli A, O'Shea PM, Wender-Ozegowska E, van Poppel MNM, Thangaratinam S, Crowther C, Biesty LM, Devane D, and Dunne FP
- Subjects
- Birth Weight physiology, Female, Humans, Infant, Newborn, Pregnancy, Premature Birth epidemiology, Treatment Outcome, Diabetes, Gestational epidemiology
- Abstract
Aims/hypothesis: The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM)., Methods: We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised., Results: Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth)., Conclusions/interpretation: This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies., Trial Registration: This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/.
- Published
- 2020
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33. Plasma Glycated CD59 Predicts Early Gestational Diabetes and Large for Gestational Age Newborns.
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Ma D, Luque-Fernandez MA, Bogdanet D, Desoye G, Dunne F, and Halperin JA
- Subjects
- Adult, Blood Glucose analysis, Diabetes, Gestational blood, Diabetes, Gestational epidemiology, Female, Fetal Macrosomia blood, Fetal Macrosomia epidemiology, Follow-Up Studies, Gestational Age, Glycosylation, Humans, Infant, Newborn, Infant, Newborn, Diseases blood, Infant, Newborn, Diseases epidemiology, Pregnancy, Pregnancy Complications blood, Pregnancy Complications epidemiology, Prognosis, Risk Factors, Young Adult, Biomarkers blood, CD59 Antigens blood, Diabetes, Gestational diagnosis, Fetal Macrosomia diagnosis, Infant, Newborn, Diseases diagnosis, Pregnancy Complications diagnosis
- Abstract
Context: Gestational diabetes mellitus (GDM) diagnosed in early pregnancy is a health care challenge because it increases the risk of adverse outcomes. Plasma-glycated CD59 (pGCD59) is an emerging biomarker for diabetes and GDM. The aim of this study was to assess the performance of pGCD59 as a biomarker of early GDM and its association with delivering a large for gestational age (LGA) infant., Objectives: To assess the performance of pGCD59 to identify women with GDM in early pregnancy (GDM < 20) and assess the association of pGCD59 with LGA and potentially others adverse neonatal outcomes linked to GDM., Methods: Blood levels of pGCD59 were measured in samples from 693 obese women (body mass index > 29) undergoing a 75-g, 2-hour oral glucose tolerance test (OGTT) at <20 weeks' gestation in the Vitamin D and Lifestyle Intervention study: the main analyses included 486 subjects who had normal glucose tolerance throughout the pregnancy, 207 who met criteria for GDM at <20 weeks, and 77 diagnosed with GDM at pregnancy weeks 24 through 28. Reference tests were 75-g, 2-hour OGTT adjudicated based on International Association of Diabetes and Pregnancy Study Group criteria. The index test was a pGCD59 ELISA., Results: Mean pGCD59 levels were significantly higher (P < 0.001) in women with GDM < 20 (3.9 ± 1.1 standard peptide units [SPU]) than in those without (2.7 ± 0.7 SPU). pGCD59 accurately identified GDM in early pregnancy with an area under the curve receiver operating characteristic curves of 0.86 (95% confidence interval [CI], 0.83-0.90). One-unit increase in maternal pGCD59 level was associated with 36% increased odds of delivering an LGA infant (odds ratio for LGA vs non-LGA infant: 1.4; 95% CI, 1.1-1.8; P = 0.016)., Conclusion: Our results indicate that pGCD59 is a simple and accurate biomarker for detection of GDM in early pregnancy and risk assessment of LGA., (© Endocrine Society 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2020
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34. Gestational diabetes prevention and treatment: a protocol for developing core outcome sets.
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Egan AM, Dunne FP, Biesty LM, Bogdanet D, Crowther C, Dempsey E, Thangaratinam S, Devane D, and Fhelelboom N
- Subjects
- Clinical Protocols, Delphi Technique, Female, Humans, Outcome Assessment, Health Care, Pregnancy, Research Design, Diabetes, Gestational prevention & control
- Abstract
Introduction: Selective reporting bias, inconsistency in the chosen outcomes between trials and irrelevance of the chosen outcomes for women, limit the efficiency and value of research for prevention and treatment of gestational diabetes mellitus (GDM). One way to address these challenges is to develop core outcome sets (COSs)., Methods and Analysis: The aim of this manuscript is to present a protocol for a study to develop COSs for GDM prevention and treatment. This is a three-phase project consisting of (1) a systematic review of the literature to create two lists of outcomes that have been reported in trials and systematic reviews of trials of interventions for the prevention and treatment of GDM, (2) a three-round, web-based e-Delphi survey with key stakeholders to prioritise these outcomes and (3) a consensus meeting to resolve any remaining disagreements and to agree on two COSs., Ethics and Dissemination: Ethical approval to conduct this study was obtained from the ethics committee at Galway University Hospitals on 13 December 2018 (Reference: C.A.2078). We will disseminate our research findings through peer-reviewed, open access publications and present at international conferences to reach a wide range of knowledge users., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2019
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35. Follow-up at 1 year and beyond of women with gestational diabetes treated with insulin and/or oral glucose-lowering agents: a core outcome set using a Delphi survey.
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Bogdanet D, Reddin C, Macken E, Griffin TP, Fhelelboom N, Biesty L, Thangaratinam S, Dempsey E, Crowther C, Galjaard S, Maresh M, Loeken MR, Napoli A, Anastasiou E, Noctor E, de Valk HW, van Poppel MNM, Agostini A, Clarson C, Egan AM, O'Shea PM, Devane D, and Dunne FP
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- Algorithms, Body Mass Index, Delivery of Health Care, Delphi Technique, Female, Follow-Up Studies, Glucose Intolerance, Humans, Insulin blood, Obstetrics organization & administration, Pregnancy, Randomized Controlled Trials as Topic, Treatment Outcome, Blood Glucose analysis, Diabetes, Gestational therapy, Hypoglycemic Agents therapeutic use, Insulin therapeutic use
- Abstract
Aims/hypothesis: Gestational diabetes mellitus (GDM) is linked with a higher lifetime risk for the development of impaired fasting glucose, impaired glucose tolerance, type 2 diabetes, the metabolic syndrome, cardiovascular disease, postpartum depression and tumours. Despite this, there is no consistency in the long-term follow-up of women with a previous diagnosis of GDM. Further, the outcomes selected and reported in the research involving this population are heterogeneous and lack standardisation. This amplifies the risk of reporting bias and diminishes the likelihood of significant comparisons between studies. The aim of this study is to develop a core outcome set (COS) for RCTs and other studies evaluating the long-term follow-up at 1 year and beyond of women with previous GDM treated with insulin and/oral glucose-lowering agents., Methods: The study consisted of three work packages: (1) a systematic review of the outcomes reported in previous RCTs of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral glucose-lowering agents; (2) a three-round online Delphi survey with key stakeholders to prioritise these outcomes; and (3) a consensus meeting where the final COS was decided., Results: Of 3344 abstracts identified and evaluated, 62 papers were retrieved and 25/62 papers were included in this review. A total of 121 outcomes were identified and included in the Delphi survey. Delphi round 1 was emailed to 835 participants and 288 (34.5%) responded. In round 2, 190 of 288 (65.9%) participants responded and in round 3, 165 of 190 (86.8%) participants responded. In total, nine outcomes were selected and agreed for inclusion in the final COS: assessment of glycaemic status; diagnosis of type 2 diabetes since the index pregnancy; number of pregnancies since the index pregnancy; number of pregnancies with a diagnosis of GDM since the index pregnancy; diagnosis of prediabetes since the index pregnancy; BMI; post-pregnancy weight retention; resting blood pressure; and breastfeeding., Conclusions/interpretation: This study identified a COS that will help bring consistency and uniformity to outcome selection and reporting in clinical trials and other studies involving the follow-up at 1 year and beyond of women diagnosed with GDM treated with insulin and/or oral glucose-lowering agents during pregnancy.
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- 2019
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36. Rates of abnormal aldosterone/renin ratio in African-origin compared to European-origin patients: A retrospective study.
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Ahmed KS, Bogdanet D, Abadi S, Dineen R, Boran G, Woods CP, Behan LA, Sherlock M, and Gibney J
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- Adult, Africa, Echocardiography, Female, Humans, Hyperaldosteronism metabolism, Hypertension metabolism, Hypokalemia metabolism, Male, Retrospective Studies, Aldosterone metabolism, Renin metabolism
- Abstract
Introduction: The aldosterone/renin ratio is the initial screening test for primary hyperaldosteronism (PHA), but little data exists regarding ethnic variations in this., Methods: Following clinical observation of a high prevalence of abnormal aldosterone/renin ratio (ARR) in patients of African-origin, we retrospectively reviewed all ARR measurements in a single centre over 10 years. Rates of hypokalaemia, intraventricular septal thickness (IVS, by echocardiography) and adrenal imaging were recorded when available., Results: Aldosterone/renin ratio was available in 1473 patients, and abnormal in 374 (25.4%). Abnormal ARR was observed in 305/1349 (22.6%) of European-origin and 69/124 (55.6%) of African-origin patients (P < 0.001). Among those with abnormal ARR, hypokalaemia (<3.5 mmol/L) was documented on at least one occasion in 171/305 (56.1%) European-origin and 43/69 (62.3%) African-origin patients (P = 0.35). Median (range) IVS was 1.57 (0.78-2.80) cm in African-origin and 1.20 (0.69-2.18) cm in European-origin patients (P < 0.002); IVS did not correlate with aldosterone or ARR however. Adrenal adenoma was identified in 41/170 (24.1%) of European-origin and 4/29 (13.7%) African-origin patients (P = 0.15), while hyperplasia was identified in 35/170 (20.5%) of European and 8/29 (27.5%) African patients (P = 0.39)., Conclusion: In summary, ARR was abnormal in 55.6% of African-origin patients screened at an Irish hospital. Rates of hypokalaemia were similar between European-origin and African-origin patients. These findings have implications for the use of current screening guidelines for ARR in African-origin patients and also for the mechanistic role of aldosterone in hypertensive complications in African-origin patients., (© 2018 John Wiley & Sons Ltd.)
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- 2019
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37. Metabolic follow-up at one year and beyond of women with gestational diabetes treated with insulin and/or oral hypoglycaemic agents: study protocol for the identification of a core outcomes set using a Delphi survey.
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Bogdanet D, Egan A, Fhelelboom N, Biesty L, Thangaratinam S, Dempsey E, Crowther C, Devane D, and Dunne F
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- Administration, Oral, Female, Follow-Up Studies, Humans, Pregnancy, Research Design, Clinical Protocols, Delphi Technique, Diabetes, Gestational drug therapy, Hypoglycemic Agents therapeutic use, Insulin therapeutic use
- Abstract
Background: Gestational diabetes (GDM) is associated with an increased lifetime risk for the development of glucose abnormalities, metabolic syndrome, cardiovascular disease, depression and tumours. Despite this high risk of additional comorbidities, there is no standardised approach to the long-term follow-up of women with a previous diagnosis of GDM. Also, there is no standardisation of outcome selection and reporting in studies involving this population. This increases the risk of reporting bias and reduces the possibility of meaningful comparisons between studies. The aim of this study is to develop a protocol for a core outcome set (COS) for the metabolic follow-up at 1 year and beyond of women with previous GDM treated with insulin and/or oral hypoglycaemic agents., Methods/design: This protocol will describe the steps that will be taken in order to develop the COS. The study will consist of three parts: (1) A systematic review of the literature of the outcomes reported in previous randomised controlled trials of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral hypoglycaemic agents; (2) A three-round, online Delphi survey with key stakeholders in order to prioritise these outcomes; and (3) A consensus meeting where the final COS will be decided., Discussion: The proposed protocol is the first step in developing a COS that will bring consistency and uniformity to outcome selection and reporting in GDM women treated with insulin and/or oral hypoglycaemic agents.
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- 2019
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38. The importance of standardisation of measurement and reference intervals for detection of phaeochromocytoma and paraganglioma (PPGL).
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Griffin TP, Bogdanet D, Navin P, Callagy G, O'Shea PM, and Bell M
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- Adrenal Gland Neoplasms pathology, Humans, Male, Middle Aged, Paraganglioma pathology, Pheochromocytoma pathology, Reference Values, Adrenal Gland Neoplasms diagnosis, Paraganglioma diagnosis, Pheochromocytoma diagnosis
- Abstract
A 51-year-old male presented 25 years ago with excessive sweating and haematuria. Blood pressure was labile. CT abdomen showed a large right-sided adrenal mass. Two 24-h urine collections showed elevated urinary catecholamines. Right adrenal resection was performed; a phaeochromocytoma (PC) was confirmed histologically. Two decades later, the patient represented with excessive sweating and measured variable blood pressure readings. Measurement of plasma metanephrines (PMets) showed elevated normetanephrine (NMN) [50,250 (R.I. 0-1180) pmol/L] and metanephrine (MN) [1030 (R.I. 0-510) pmol/L] values. CT abdomen showed a 100 × 90 × 63 mm enhancing mass in the right retroperitoneum. Curative resection was undertaken confirming recurrent PC. Follow-up post-resection, plasma NMN was discordant, 1314 pmol/L (above decision threshold) at 30 min and 911 pmol/L (below decision threshold) at 40 min. Acute clinical awareness of persistent disease mandated the performance of a metaiodobenzylguanidine (MIBG) scan and CT abdomen. These confirmed residual disease in the upper right side of the retroperitoneum. Persistent disease following redo surgery could have been missed if only seated-sampling upper reference limits were applied to PMets collected at 40 min. Our experience with this patient triggered a review of our PMets sampling strategy. There was no statistically significant difference in PMets sampled at 30 and at 40 min seated-rest. Optimum diagnostic test accuracy was achieved using a supine-sampling strategy at a single time point (30 min). Our case highlights the importance of maintaining a high index of clinical suspicion for residual/recurrent disease in the face of inconclusive biochemistry, followed by appropriate targeted radiology using MIBG or PET-CT in patients with PPGL.
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- 2018
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39. ATLANTIC DIP: Despite insulin therapy in women with IADPSG diagnosed GDM, desired pregnancy outcomes are still not achieved. What are we missing?
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Bogdanet D, Egan A, Reddin C, Kirwan B, Carmody L, and Dunne F
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- Adult, Cohort Studies, Diabetes, Gestational diagnosis, Female, Humans, Insulin pharmacology, Pregnancy, Pregnancy Outcome, Retrospective Studies, Diabetes, Gestational drug therapy, Fetal Macrosomia etiology, Insulin therapeutic use, Pregnancy Complications etiology
- Abstract
Aims: To assess if pregnancy outcomes for women with GDM treated with insulin (GDM-I) are comparable to outcomes for women with GDM treated with medical nutritional therapy (MNT) (GDM-M)., Materials and Methods: This retrospective cohort study included 752 women with GDM-I and 567 women with GDM-M. Maternal and foetal outcomes were examined., Results: Women with GDM-I had a greater risk of polyhydramnios (aOR 2.33, 95%CI 1.31-4.14) and were more likely to deliver by caesarean section (CS) (aOR 1.67, 95%CI 1.25-2.23). Their offspring had higher rates of macrosomia (22.2% vs 12.7%; p < .01), large for gestational age (LGA) (19.7% vs 12.5%; p < .01) and were more likely to require neonatal intensive care unit (NICU) admission (aOR 4.88, 95%CI 3.54-6.73). There was no difference between the groups in rates of pre-eclampsia (PET), pregnancy-induced hypertension (PIH), infant mortality, congenital malformations, neonatal hypoglycaemia, prematurity and rates of small for gestational age (SGA)., Conclusions: GDM-I and GDM-M mothers have similar rates of maternal medical morbidities. Despite this, the rate of delivery by CS remains greater, possibly driven by physician choice for elective intervention in the GDM-I group. Despite insulin therapy, offspring of GDM-I mothers experience higher rates of macrosomia, LGA and NICU admissions. This may be related to the higher baseline risk profile in GDM-I women, to sub-optimal glycaemic control, excessive gestational weight gain (GWG) or higher baseline BMI of the mother. Addressing baseline maternal BMI, limiting excessive GWG and tightening glycaemic control in GDM-I women may translate to better pregnancy outcomes., (Copyright © 2017 Elsevier B.V. All rights reserved.)
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- 2018
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40. Endocrinopathies and renal outcomes in lithium therapy: impact of lithium toxicity.
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Dineen R, Bogdanet D, Thompson D, Thompson CJ, Behan LA, McKay AP, Boran G, Wall C, Gibney J, O'Keane V, and Sherlock M
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- Antipsychotic Agents therapeutic use, Female, Humans, Ireland, Lithium Compounds therapeutic use, Male, Middle Aged, Retrospective Studies, Antipsychotic Agents adverse effects, Bipolar and Related Disorders drug therapy, Hypercalcemia chemically induced, Hyperparathyroidism chemically induced, Lithium Compounds adverse effects, Renal Insufficiency chemically induced
- Abstract
Background: Lithium is the mainstay of treatment for bipolar disorder, mania and an augmentation therapy in patients with treatment resistant depression. It has a narrow therapeutic index, with recognized adverse multi-system and endocrine side effects., Aim: To assess the impact of lithium therapy, in particular lithium toxicity, on the development of endocrine and renal disorders in a cohort of patients in a single tertiary referral centre in Ireland., Study Design: A retrospective analysis was performed of the prevalence of lithium toxicity and renal, thyroid and parathyroid dysfunction in our study population., Methods: We collected laboratory data from the Clinical Chemistry department of the Adelaide and Meath Hospital incorporating the National Children's Hospital (AMNCH), Dublin, Ireland. Our study population included all patients who had at least one serum lithium measurement from January 1st 2000 to December 31st 2014 inclusive., Results: A total of 580 patients were included in the study. Among our study group, 70 patients (12.1%) had 1 toxic lithium measurement (lithium level >1.2 mmol/l). 27.8% (n > 161) of patients developed stage 3 Chronic kidney Disease (CKD) or higher, which was commoner in those patients who developed toxic lithium levels (P < 0.0001) and in those who developed hypernatraemia (P > 0.0001). 16.2% of patients (n > 94) had one serum sodium >145 mmol/l during follow up. 60 patients(10.3%) had a TSH >10 mU/l, while complete suppression of TSH (<0.05 mU/l) was observed in 22 patients (3.8%) during follow-up. 4% (n > 37) of the study population had ≥1 serum corrected calcium level > 2.55 mmol/l, and 4 patients had biochemical confirmation of primary hyperparathyroidism but PTH levels were only performed in 2.8% (n > 16) of the studypopulation., Conclusion: Stage 3 CKD is common in patients receiving lithium therapy. Lithium toxicity is associated with CKD and hypernatraemia. Thyroid dysfunction and hypercalcaemia are common in patients receiving lithium therapy. Patients receiving lithium therapy require surveillance of renal, thyroid and bone biochemistry.
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- 2017
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41. ATLANTIC DIP: Insulin Therapy for Women With IADPSG-Diagnosed Gestational Diabetes Mellitus. Does It Work?
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Bogdanet D, Egan AM, Reddin C, Kgosidialwa O, Kirwan B, Carmody L, and Dunne FP
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- Adult, Case-Control Studies, Cohort Studies, Female, Humans, Hypertension, Pregnancy-Induced epidemiology, Infant, Newborn, Infant, Newborn, Diseases epidemiology, Infant, Small for Gestational Age, Intensive Care Units, Neonatal statistics & numerical data, Logistic Models, Male, Multivariate Analysis, Odds Ratio, Pregnancy, Pregnancy Complications epidemiology, Retrospective Studies, Uterine Hemorrhage epidemiology, Diabetes, Gestational drug therapy, Fetal Macrosomia epidemiology, Hypoglycemia epidemiology, Hypoglycemic Agents therapeutic use, Insulin therapeutic use, Polyhydramnios epidemiology, Postpartum Hemorrhage epidemiology, Pre-Eclampsia epidemiology
- Abstract
Introduction: Approximately 40% of women with gestational diabetes mellitus (GDM) diagnosed using International Association of the Diabetes and Pregnancy Study Group (IADPSG) criteria require insulin therapy., Objective: We assessed whether the outcomes for women with GDM treated with insulin are comparable to women with normal glucose tolerance (NGT)., Materials and Methods: This retrospective cohort study included 752 women with insulin-treated GDM and 2496 women with NGT during pregnancy. Maternal and fetal outcomes were examined., Results: Infants of women with insulin-treated GDM had rates of macrosomia [adjusted odds ratio (aOR), 1.19; 95% confidence interval (CI), 0.87 to 1.63; P = 0.26], large for gestational age (LGA) (aOR, 1.07; 95% CI, 0.77 to 1.47; P = 0.67), and small for gestational age (SGA) (aOR, 0.70; 95% CI, 0.38 to 1.38; P = 0.26) similar to women with NGT. They were more likely to be hypoglycemic at birth (aOR, 6.85; 95% CI, 2.31 to 20.28; P < 0.01) and to require neonatal intensive care unit care (NICU) (aOR, 12.09; 95% CI, 8.72 to 16.76; P < 0.01), predominantly for nonmedical reasons. Maternal rates of hypertensive disorders (preeclampsia: aOR, 0.64; 95% CI, 0.34 to 1.12; P = 0.17; pregnancy-induced hypertension: aOR, 1.11; 95% CI, 0.74 to 1.66; P = 0.60) and hemorrhage (ante partum hemorrhage: aOR, 0.56; 95% CI, 0.19 to 1.58; P = 0.27; postpartum hemorrhage: aOR, 1.17; 95% CI, 0.68 to 2.03; P = 0.55) were similar between groups, but the risk of polyhydramnios was increased in the GDM cohort (aOR, 7.75; 95% CI, 3.96 to 15.16; P < 0.01)., Conclusions: Insulin treatment of IADPSG-diagnosed GDM results in rates of macrosomia, LGA, SGA, and maternal hypertensive disorders similar to those of women with NGT. Although NICU admissions are greater in the GDM cohort, they are primarily for nonmedical reasons. Neonatal hypoglycemia and polyhydramnios remain greater among women with insulin-treated GDM., (Copyright © 2017 by the Endocrine Society)
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- 2017
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