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In patients with type 2 diabetes mellitus (T2DM) who require additional glucose-lowering on top of first-line metformin monotherapy, sulfonylureas are the most common choice for second-line therapy followed by dipeptidyl peptidase inhibitors (DPP-4i). This article summarises presentations at a symposium entitled "Real-World Evidence and New Perspectives with Gliclazide MR" held at the International Diabetes Federation Congress in Busan, South Korea on 4 December 2019. Although guideline recommendations vary between countries, the guidelines with the highest quality ratings include sulfonylureas as one of the preferred choices as second-line therapy for T2DM. Data from randomised controlled trials (RCTs) have consistently demonstrated that sulfonylureas are effective glucose-lowering agents and that the risk of severe hypoglycaemia with these agents is low. In addition, both RCTs and real-world observational studies have shown no increased risk of mortality or cardiovascular disease with the use of newer-generation sulfonylureas compared with other classes of glucose-lowering treatments. However, differences between sulfonylureas do exist, with gliclazide being associated with a significantly lower risk of mortality or cardiovascular mortality compared with glibenclamide, as well as the lowest incidence of severe hypoglycaemia compared with other agents in this class. Recent real-world studies into the effectiveness and safety of gliclazide appear to confirm these findings, and publication of new data from these studies in patients with T2DM in the UK, and in Muslim patients who are fasting during Ramadan, are awaited with interest. Another study being undertaken with gliclazide is a pan-India study in patients with maturity-onset diabetes of the young (MODY) subtypes 1, 3 and 12. Patients with these MODY subtypes respond particularly well to sulfonylurea treatment, and sulfonylureas are the first-line agents of choice in these patients. These new and ongoing studies will add to the cumulative data on the efficacy and safety of certain sulfonylureas in patients with diabetes.

Introduction To describe the characteristics and care of participants with type 1 diabetes during Ramadan in the Middle East and North Africa. Methods The DAR-MENA (Diabetes and Ramadan—Middle East and North Africa) study was a prospective, observational study of adults with type 1 and type 2 diabetes who were Muslim and did/did not intend to fast during Ramadan 2016. Baseline data were collected 6 weeks prior to Ramadan, with a follow-up visit 1–2 months after Ramadan. This is the analysis of the population with type 1 diabetes. Measurements included proportion who fasted, reasons for fasting and not fasting, changes in diabetes treatment, hypoglycemic events, and proportion with access to diabetes education. Results Of 136 participants with type 1 diabetes, 76.9% (100/130) fasted for at least 1 day, 72.3% (94/130) fasted for at least 15 days, and 48.5% (63/130) fasted for 30 days. The majority (63.0%, 63/100) reported personal decision as a reason to fast. Fear of diabetic complications (58.6%, 17/29) and previous complications related to fasting (48.3%, 14/29) were the most common reasons for not fasting. Adjustment of diabetic medication regimen occurred for 84.6% (115/136) of participants, and 72.8% (99/136) changed their treatment dose. The incidence and number of adverse events for confirmed and severe hypoglycemia were similar before and during Ramadan. Almost half of participants had access to diabetes education (45.6%, 62/136). Conclusion The DAR-MENA study showed that despite the risks associated with fasting for people with type 1 diabetes, almost half fasted for the full 30 days of Ramadan with no significant change in hypoglycemia events. Since the current International Diabetes Federation and Diabetes and Ramadan guidelines do not endorse fasting for people with type 1 diabetes, it is important that those who insist on fasting work closely with their healthcare practitioner to avoid any complications. Electronic Supplementary Material The online version of this article (10.1007/s12325-020-01267-4) contains supplementary material, which is available to authorized users.

Objectives To systematically review and synthesize literature on 1) the overall prevalence of depression and anxiety in SLE patients in identified studies, and 2) the pooled prevalence per metrics of depression and anxiety in adult SLE patients. Methods This review used (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) PRISMA guidelines and in-depth searches in four databases (1954-2016; Ovid-based Medline, Embase, PsycINFO and CINAHL) to identify articles on the prevalence of depression and/or anxiety in adult SLE patients. Included studies were critically appraised and analyzed. The prevalence of depression and anxiety was studied for all included studies, and whenever possible, pooled prevalence (PP) was determined for more commonly used metrics. Statistical and publication bias was assessed using funnel plots. Result A total of 3103 references were identified, 226 were selected for detailed review and 72 were included in the final analysis. Overall Prevalence The depression PP, obtained from 69 studies representing 23,386 SLE patients, was 35.0% (95% CI: 29.9%-40.3%). The anxiety PP, obtained from 38 studies representing 4439 SLE patients, was 25.8% (95% CI: 19.2%-32.9%). Prevalence per metrics used The more commonly used instruments included the Centre for Epidemiological Studies - Depression (CES-D), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Hospital Anxiety and Depression Scales (HADS-A/D), and Hamilton Rating Scales for Depression/Anxiety (HAM-D/A)]. The CES-D was utilized in 13 studies including 1856 SLE patients; depression PP was 41.5% (95% CI: 35.1%-48.1%). The BDI was utilized in 14 studies including 1355 SLE patients and the BAI in 3 studies including 489 patients; depression PP was 39.9% (95% CI: 31.1%-49.1) and anxiety PP was 38.4% (95% CI: 34.2%-42.8%). The HADS-D was utilized in 14 studies including 1238 SLE patients and the HADS-A in 12 studies including 1099 patients respectively; it's depression PP was 24.4% (95% CI: 19.1%-30.1%) and anxiety PP was 38.3% (95% CI: 29.1%-47.9%). The HAM-D was utilized in 4 studies including 267 SLE patients and the HAM-A in 4 studies including 213 patients respectively; its depression PP was 40.0% (95% CI: 23.0%-59.0%) and anxiety PP was 39.0% (95% CI: 32.0%-45.0%). Conclusion There was high variability in the prevalence of depression and anxiety, ranging from 8.7%-78.6% and 1.1%-71.4%, respectively. This could be attributed to the lack of consistency in the metrics used and its definition for depression and anxiety in SLE. Studies that used a specific metric, such as the CES-D, BDI or HAM-D, yielded similar depression prevalence. The HADS-D had the lowest prevalence. All metrics of anxiety yielded similar anxiety prevalence.

Background: Diabetes mellitus is a leading cause of morbidity and mortality worldwide, imposing a considerable burden on health systems and societies as it affects both individuals and their families and has a large impact on the economic and social development of a country. Objectives: The purpose of this study was to study the prevalence of diabetes and pre-diabetes among the Dubai population and associations with diabetes risk factors. Methodology: A cross-sectional Diabetes Household Survey was carried out in the Emirates of Dubai during 2017 as a complementary stage of the Dubai Household Survey, 2014, which was a randomly selected, multistage, stratified, cluster survey. The sampling technique was selected to assess the rates of undiagnosed diabetes as well as the rates of pre-diabetes through screening with HbA1c. The size of the 2017 survey sample was estimated at 300 individuals for Emirati and 300 for non-Emirati. An additional 200 individuals were added to address non-response cases. These were added to those who were identified as diabetics in the 2014 Household Health Survey and then weighted to give a representative sample for the Dubai population. Results: The study revealed that the prevalence of diabetes in Dubai among UAE nationals was 19%, and it was 14.7% for expats. Consequently, the overall prevalence of diabetes in Dubai is 15.2%. Undiagnosed diabetes was 10% in UAE nationals and 10.9% in expats. Pre-diabetes in UAE national males was lower than in females, although this pattern was not observed among expats. Younger age, normal weight, and exercise were associated with lower rates of diabetes and pre-diabetes in UAE nationals and expats. Hypertension was associated with higher rates of diabetes regardless of nationality. Conclusions: The study concluded that the prevalence of diabetes among the Dubai population is alarmingly high and that a large proportion of the population are not aware of their diagnosis. A higher prevalence of diabetes is associated with multiple factors, such as age, male gender, hypertension, higher BMI, lack of exercise, and lower level or no education, as well as a family history of diabetes mellitus. Many of these factors can be easily modified, which could lead to a decrease in the burden of the disease.

Background: Oral cancer is currently a major global health issue. In developing countries, oral cavity cancer is estimated to be the third most common malignancy after cancer of the cervix and stomach. Surgical excision plays a major role in the treatment of oral cavity cancer patients. Objective: The aim of the study was to compare between pedicled and free flaps used for oral cavity reconstruction after ablation of squamous cell carcinoma. Patients and methods: This is a prospective comparative study that included 41 patients at National Cancer Institute (NCI) of Cairo University and Aswan University Hospital in the period from 2015 to 2018. Patients were selected from those who were attending the Outpatient Clinic of Head and Neck Surgery Unit at NCI, Cairo University and Aswan University Hospital. Results: Detection of short-term functional outcome regarding the swallowing, speech and oral competence, Contralateral Submental Island Flap (CSMIF) followed by Radial Forearm Free Flap (RFFF) showed better functional results than other flaps. The cosmetic outcome was better in 50% of CSMIF & RFFF cases. The Thoracodorsal Artery Perforator Flap (TDAPF) cases showed a slightly higher care costs than other cases although in other specialized centers the care costs were found to be higher in RFFF cases than others. Conclusion: Oncologic outcomes were better with CSMIF and cosmetic outcomes were better in CSMIF and RFFF cases. Relatively, TDAP flap cases were higher than others in the overall care costs.

Rapid urbanisation and socioeconomic development in the United Arab Emirates (UAE) have led to the widespread adoption of a sedentary lifestyle and Westernised diet in the local population and consequently a high prevalence of obesity and diabetes. In 2019, International Diabetes Federation statistics reported a diabetes prevalence rate of 16.3% for the adult population in the UAE. In view of the wealth of recent literature on diabetes care and new pharmacotherapeutics, the Emirates Diabetes Society convened a panel of experts to update existing local guidelines with international management recommendations. The goal is to improve the standard of care for people with diabetes through increased awareness of these management practices among healthcare providers licensed by national health authorities. These consensus guidelines address the screening, diagnosis and management of type 2 diabetes mellitus in adults including individuals at risk of developing the disease.

Background: Head and neck cancers represent the sixth most common cancer worldwide with an incidence of over 600,000 new cases per year. More than 90% of head and neck cancers are squamous cell carcinomas (SCC) that arise from the mucosal surfaces of the oral cavity, oropharynx and larynx. Objective: The aim of the current work was to investigate the predictors of complications after flap reconstruction of oral cavity defects following ablation of squamous cell carcinoma. Patients and methods: This prospective comparative study included a total of 41 patients who diagnosed to have oral SCCs, attending at the outpatient clinic of Head and Neck Surgery Unit, National Cancer Institute (NCI), Cairo University and Aswan University Hospital. Written informed consent of all the subjects was obtained after explaining the benefits and hazards for each method step. This study was conducted between 2015 to 2018. Approval of the ethical committee was obtained. Results: Patients with positive history of neoadjuvant chemoradiotherapy (CRTH) are 52% less likely to developing complications than those with negative history of neoadjuvant CRTH. Detection of the short-term oncologic outcome; in the 4 flaps was better in contralateral submental island flap (CSMIF) cases than others. CSMIF were found to be 58% less liable for recurrence in comparison with pectoralis major myocutaneous flap (PMMCF) that was why it didn't show any clinical or radiologically detectable recurrence within the period of 24 months postoperatively. Thoracodorsal artery perforator (TDAP) flaps were 2.6 times more liable for recurrence in comparison with PMMCF. RFFF flaps were found to be 1.2 times more liable for recurrence in comparison with PMMCF. Conclusion: The chosen 4 flaps for this study are applicable to be used for post ablative oral cavity reconstruction. Our flaps were equal in suitability for defect coverage (50-60%).

ObjectiveTo study the prevalence of overweight and obesity and determine the associated risk factors among adults in Dubai.Design and settingA cross-sectional survey with a multistage, stratified random sampling design was conducted in the Emirate of Dubai in 2019.ParticipantsThe study included 2142 adults aged 18+ years in the Emirate of Dubai.ResultsThe overall prevalence of obesity, which was defined as body mass index (BMI) ≥30 kg/m2, was 17.8%. The highest obesity rates were reported among women (21.6%) and the United Arab Emirates (UAE)-nationals (39.6%). Moreover, 39.8% of the population was overweight (BMI ≥25–29.9 kg/m2). Multivariate logistic regression showed associations between obesity and age, sex, nationality, hypertension and occupation. Obesity increases with age, with the highest risk at age group 50–59 years (OR 4.30; 95% CI 1.57 to 11.78) compared with the reference group (18–24 years). Females had a higher risk of obesity than males (OR 1.62; 95% CI 1.10 to 2.38). Compared with those in the reference group (Western and others), UAE nationals, other Arabs and Asians were more likely to be obese ((OR 2.08; 95% CI 1.18 to 3.67), (OR 3.61; 95% CI 2.41 to 5.44) and (OR 1.98; 95% CI 1.12 to 3.50), respectively). Clerical and service workers (OR 4.50; 95% CI 2.54 to 8.00) and elementary and unskilled occupation categories (OR 2.57; 95% CI 1.56 to 4.25) had higher risks of obesity than the reference group (professionals), pConclusionsObesity and overweight are highly prevalent among adults in Dubai and are remarkably associated with sociodemographic and behavioural risk factors. Comprehensive strategic initiatives are urgently needed to control obesity in the high-risk populations in the Emirate of Dubai.

To evaluate the safety and effectiveness of insulin glargine 300 U/mL (Gla-300) in people with type 2 diabetes mellitus (T2DM) in the Gulf region who fast during Ramadan.ORION was a real-world, prospective, observational study in people with T2DM treated with Gla-300 during pre-Ramadan, Ramadan, and post-Ramadan periods. This subgroup analysis included 222 participants from the Gulf region (Kuwait, Saudi Arabia, United Arab Emirates, and Qatar). The primary endpoint was the percentage of participants experiencing severe and/or symptomatic documented hypoglycemia (self-monitored plasma glucose [SMPG] ≤ 70 mg/dL) during Ramadan. Changes in glycated hemoglobin (HbAThe primary endpoint was reported in one (0.5%) participant during Ramadan. The incidence rate of symptomatic documented hypoglycemia (SMPG ≤ 70 mg/dL) decreased from the pre-Ramadan (3.2%) to Ramadan period (0.5%), and no severe hypoglycemia events were reported during the study. Reductions were observed in HbAIn a real-world setting in the Gulf region, Gla-300 treatment in people with T2DM during Ramadan was associated with a low incidence of hypoglycemia and improved glycemic control.CTRI/2019/02/017636.

Fasting during Ramadan is one of the five pillars of Islam and is obligatory for all healthy Muslims from the age of puberty. Though individuals with some illness and serious medical conditions, including some people with diabetes, can be exempted from fasting, many will fast anyway. It is of paramount importance that people with diabetes that fast are given the appropriate guidance and receive proper care. The International Diabetes Federation (IDF) and Diabetes and Ramadan (DaR) International Alliance have come together to provide a substantial update to the previous guidelines. This update includes key information on fasting during Ramadan with type 1 diabetes, the management of diabetes in people of elderly ages and pregnant women, the effects of Ramadan on one's mental wellbeing, changes to the risk of macrovascular and microvascular complications, and areas of future research. The IDF-DAR Diabetes and Ramadan Practical Guidelines 2021 seek to improve upon the awareness, knowledge and management of diabetes during Ramadan, and to provide real-world recommendations to health professionals and the people with diabetes who choose to fast.

Summary Background Calciphylaxis is a life-threatening cutaneous ulcerative/necrotic disease characterized by vascular calcification/occlusion. It occurs most commonly in end-stage kidney disease (ESKD), known as uraemic calciphylaxis (UC) but can also occur in patients with chronic kidney disease (CKD) and normal kidney function (nonuraemic calciphylaxis; NUC). There are few large series of NUC in the literature. Aim To compare the clinicopathological features of UC and NUC. Methods We retrospectively compared the clinicopathological features of 35 patients with NUC during the period 2010–2020 with those of 53 patients with UC (control group). Cases were classified as NUC in the absence of all of the following: ESKD, significant CKD (defined as serum creatinine > 3 mg/dL or creatinine clearance < 15 mL/min) and acute kidney injury requiring kidney replacement therapy or kidney transplantation. Results NUC represented 40% of the total cases, and there was a higher number of women (P < 0.01) and a higher median body mass index (P = 0.06) compared with the control UC group. Elevated parathyroid hormone was present in 44% of patients with NUC. Most of the tested patients were positive for lupus anticoagulants (56%). NUC biopsies showed a higher rate of extravascular calcium deposits (73% vs. 47%, P = 0.03). Dermal reactive vascular proliferation was the most common dermal change (32%). Conclusions NUC is more common than previously reported and shows a higher predilection for obese postmenopausal women. Undiagnosed hyperparathyroidism shows a possible association with NUC. Lupus anticoagulants were positive in most patients. NUC biopsies are more likely than UC biopsies to display extravascular calcium deposition.

Bacillary angiomatosis (BA) is an uncommon systemic disease caused by Bartonella henselae (BH) or Bartonella quintana (BQ) that occurs primarily in immunocompromised hosts. Few cases of BA recipients have been reported in adult solid transplant recipients over the years, with most cases presenting years after transplant. We describe a case of a kidney transplant recipient who developed cutaneous BA very early in the post-transplant period despite not having any exposures. Retrospective testing of donor and recipient's serum was performed and raised the concern for possible donor-derived infection. A literature review encompassing 1990 to present was also performed in order to better understand the clinical presentation, diagnostics and therapeutic approach of this unusual disease. Combined serology, histopathology and molecular testing (polymerase chain reaction [PCR]) were useful in diagnosing BA in our patient as serology alone might be unreliable. Macrolides or doxycycline for at least 3 months is the recommended therapeutic strategy; however, the optimal duration of treatment is not well established in transplant recipients. In our patient, we decided to use doxycycline for 1 year due to gradual resolution of lesions and ongoing immunosuppression. Patient responded successfully without any documented relapse.

IDF-DaR guidelines recommend change of basal insulin timing to early evening. Randomized trials examining timing of basal insulin during fasting are lacking. Objective: To compare glucose profiles in T1DM patients taking Glargine at early evening (6-7 pm) versus bedtime (10-12 night) during fasting Ramadan. Methods: Multicenter open label randomized controlled trial. Patients recruited in 4 centers from 4 cities in Saudi Arabia. Data collected using pre- and post-Ramadan questioners. Glucose data collected via self-monitoring (Roche AccuCheck glucometer/the Abbott Freestyle Libre), and Envision iPro CGM. Results: 185 T1DM patients randomized; 91 to glargine at 6-7pm (early), and 94 at 10-12 night (late). 32.4% ≤18 years, 53% female, and average duration of DM 11 ±11. No significant differences between the two groups in demographics or DM complications. Early vs. late group: Pre Ramadan A1c 9 ±2.7 vs. 8.75 ±2.1, p=0.35, post Ramadan A1c 8.4 ±2.9 vs. 8.7 ±2.7, p=0.5. Breaking of fast reported in 66 (75.9%) vs. 71 (76.3%), p=0.94; average number of days 4±6 vs. 4±4, p=0.5, and due to hypoglycemia in >90% of cases for both groups. Hypoglycemia most common in Morning 32 (59.3%) vs. 38 (60.35%), p=0.85. Severe hypoglycemia reported in 2 vs. 5 patients, and 1 DKA admission in each group. Combined CGM data during Ramadan: A1c 7.6 ±1.7 vs. 7.7 ±2.1, p=0.63. Average Time in range of 70-180 mg/dl 44.6% vs. 46.1%, p=0.7, Time below range (180mg/dl) 47.5 vs. 47.5%, p=0.99. Total hypoglycemic episodes detected by SMBG 4 ±6 vs. 3 ±8, p=0.3, and Low excursions detected by iPro CGM 5 ±6 vs. 4 ±5.5, p=0.22, with AUC below limit 0.5 ±1 vs. 0.15 ±0.85, p=0.03. Conclusion: Changing glargine timing during Ramadan to early evening hours carries no significant advantage over keeping at bedtime in regards to hypoglycemia and overall glucose profiles. ClinicalTrials.gov: NCT04383990. Disclosure R. Alamoudi: None. M. Hassanein: None. G. S. Khogeer: None. A. Al qarni: None. Y. M. Saleh: Advisory Panel; Self; American Association of Clinical Endocrinologists, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk, Research Support; Self; Servier Laboratories, Speaker’s Bureau; Self; Abbott Diabetes, Amgen Inc., Ascensia Diabetes Care, Lilly Diabetes, Sanofi-Aventis. A. Aljawhrji: None. M. R. Alsubaiee: None. H. A. Zarif: Advisory Panel; Self; Pfizer Foundation, Speaker’s Bureau; Self; Medtronic. S. B. Alaidarous: Other Relationship; Self; AstraZeneca, Novo Nordisk. S. A. Khashwayn: None. Funding King Abdullah International Research Center

Monoclonal antibodies (mAbs) are a leading class of biotherapeutics. In oncology, patients often fail on early lines of biologic therapy to a specific target. Some patients may then enroll in a new clinical trial with a mAb specific for the same target. Therefore, immunoassays designed to quantify the current mAb therapy or assess immunogenicity to the drug may be susceptible to cross-reactivity or interference with residual prior biologics. The impact of two approved anti-PD-1 mAbs, pembrolizumab and nivolumab, was tested in several immunoassays for cemiplimab, another approved anti-PD-1 mAb. The methods included a target-capture drug concentration assay, a bridging anti-drug antibody (ADA) assay and a competitive ligand-binding neutralizing antibody (NAb) assay. We also tested bioanalytical strategies to mitigate cross-reactivity or interference in these assays from other anti-PD-1 biologics. Both pembrolizumab and nivolumab cross-reacted in the cemiplimab drug concentration assay. This was mitigated by addition of antibodies specific to pembrolizumab or nivolumab. ADA specific for pembrolizumab and nivolumab did not interfere in the cemiplimab ADA assay. However, pembrolizumab and nivolumab generated a false-positive response in a target-capture NAb assay. Our results demonstrate that similar exogenous pre-existing anti-PD-1 mAbs (biotherapeutics) such as pembrolizumab and nivolumab are detected and accurately quantified in the cemiplimab drug concentration assay. However, once steady state is achieved for the new therapy, prior biologics would likely not be detected. Cross-reactivity and interference in immunoassays from previous treatment with class-specific biotherapeutic(s) pose significant bioanalytical challenges, especially in immuno-oncology. Graphical abstract

Granulomatous tubulointerstitial nephritis (GTIN) is a rare pathologic finding on kidney biopsy. GTIN can be associated with drugs, infection, systemic granulomatous disease, and tubulointerstitial nephritis with uveitis syndrome. We present a case of GTIN in a kidney transplant recipient (KTR) and a literature review of published cases of GTIN in KTRs.A 65-year-old man with a history of pulmonary and ocular tuberculosis (TB), who had undergone deceased donor kidney transplant 8 years prior, was admitted for acute kidney injury, hypercalcemia, and uveitis. His medications included rifabutin, isoniazid, and tacrolimus. Serum laboratory tests revealed creatinine of 2.65 mg/dL (baseline 1.1-1.5 mg/dL) and corrected calcium of 13.2 mg/dL. Hypercalcemia workup showed parathyroid hormone 7 pg/mL, 1,25(OH) vitamin D 54 pg/mL, parathyroid hormone-related peptide2.0 pmol/L, and angiotensin-converting enzyme 47 U/L. Kidney biopsy showed GTIN with noncaseating granulomas. Universal polymerase chain reaction testing for acid-fast bacilli, fungus, and bacteria was negative. He was treated with prednisone, and his kidney function returned to baseline, and his hypercalcemia resolved.GTIN is a rare entity seen in less than 1% of transplanted kidney biopsies. The exactly etiology of this GTIN case remains unknown. TB could not be entirely ruled out, because the patient was receiving active anti-TB therapy. Our literature review showed infection to be the leading cause of GTIN in KTRs and that GTIN with concomitant uveitis remains exceedingly rare. Steroids may be useful in certain cases.

Peritoneal dialysis associated infections are common and associated with high morbidity and mortality, if not treated in a timely manner.

We aimed to describe the characteristics and care of participants with diabetes during Ramadan in the Middle East and North Africa (MENA).In this prospective, observational study, we analysed the number of fasted days, number of participants fasting, glycemic control, rate of hypoglycemic events, and lifestyle patterns for participants with T2DM during Ramadan 2016.The population included 1749 participants with T2DM. The mean (SD) duration of fasting was 27.7 (5.0) days, and 57.3% of participants fasted for the full duration of Ramadan. Following Ramadan, a significant improvement in HbA1c, FPG, and PPG was observed (p 0.0001). Confirmed hypoglycemia increased significantly from before to during Ramadan (incidence: 4.9% vs. 10.4%, p 0.001; adverse events: 0.11 vs. 0.22 events/month/participant, p 0.001) and was dependent on the treatment regimen. Severe hypoglycemia incidence was 0.2% before versus 0.9% during Ramadan (p = 0.031), whereas adverse events remained comparable (0.01 events/month/participant; p = 0.154). Most participants (97.4%) reported lifestyle changes during Ramadan.This prospective study is the first to describe the characteristics and care of participants with T2DM during Ramadan in MENA, and can be utilized in the development of evidence-based care to ensure the safety of participants who fast.

To understand the risk of hypoglycaemia during Ramadan fasting by use of CGM, as well as to observe the Glycemic control and renal functions in patients with diabetes and chronic kidney disease stage 3 (CKD-3).A prospective interventional study conducted in the Dubai Hospital, a tertiary care centre in the United Arab Emirates, during the month of Ramadan 1437 AH (Hijri), which corresponded to June 6th till July 5th, 2016. 25 patients with type 2 diabetes and stage 3 chronic kidney disease (CKD stage 3) were included in the study, who intended to fast during Ramadan. The aim was to observe the serum glucose level through 24 h FreeStyle Libre flash continuous glucose monitor (FSL-CGM). Most patients had three sensors during the study, covering an average three weeks during Ramadan and three weeks outside Ramadan (Sha'ban and shawal). We also monitored the change in, BP, HBA1c, kidney functions and BMI before and after Ramadan.This study included 25 adults with a mean age of 60 (±14 years). Fasting Ramadan did not result in any significant change in biophysical and biochemical profile of these patients. Data from FSL-CGM showed significantly longer duration (101.9 ± 119.1 Vs. 45.9 ± 47.6 min, p 0.033) and more frequent hypoglycemic episodes (4.4 ± 4.7 Vs. 2.3 ± 3.0, p 0.047) during Ramadan compared tonon-Ramadan respectively. The mean blood glucose readings were also significantly lower (70.7 ± 29.3 Vs.93.7 ± 57.9 mg/dl p 0.011) during Ramadan compared to non -fasting period. The renal function mean ± SD (serum creatinine 1.48 ± 0.37, 1.44 ± 0.37 and eGFR, 49.0 ± 18.4, 48.9 ± 17.5 p 0.9) showed no significant change due to fasting.In patients with diabetes and CKD-stage 3 Ramadan fasting under close supervision and optimal diabetes care, was not associated with worsening of HBA1c and renal function. Patients had significantly more frequent and prolonged hypoglycemic episodes during Ramadan.

To describe the risk of hypoglycaemia during Ramadan and determine its risk factors, and the impact of hypoglycaemia on patients' behaviour.A cross-sectional multi-country observational study, with data captured within 6 weeks after Ramadan 2015. Patients' and disease characteristics and its management, the risk of hypoglycaemia and patients' response to hypoglycaemia were recorded.A cohort of 1759 patients; majority with type 2 diabetes mellitus from North Africa, Arabian Gulf, Saudi Arabia, and the Indian subcontinent. Hypoglycaemia was reported by 290 patients (16.8%); particularly affecting type 1 diabetes patients and in insulin-treated patients in general. Age was significantly younger in the hypoglycaemia group (P 0.001). The commonest responses were reducing the dose or frequency of medications (42%), attending primary care providers (24.5%) or increasing monitoring (20.7%). Fasting was interrupted by 67% only of those who experienced hypoglycaemia and recourse to emergency services was pursued by less than a quarter of patients with hypoglycaemia. The country-wise analysis of the rates of hypoglycaemia was greatest in Egypt (51.3%) and lowest in Pakistan (3.5%).Hypoglycaemia is a significant complication of fasting during Ramadan. It may be predicted by type of diabetes, and use of insulin. Patients' responses are varied and call for more formal pre-Ramadan education.

Aim Most of Muslims patients with diabetes and Coronary Heart Disease (CHD) elect to fast in Ramadan, but the actual risk in this subset of patients with diabetes is largely unknown. We aimed to understand the safety of fasting in CHD patients with diabetes insisting on fasting Ramadan under optimal care. We also monitored the change in biophysical and biochemical parameters of these patients before and after Ramadan. We conducted this prospective study in a tertiary care hospital in Dubai during Ramadan 2016, (June 6th till July 5th). Patients and methods 21 Patients with T2DM with stable known CHD during the three months prior to study and insisted on fasting despite advice against it were recruited for the study. All patients received continuous glucose monitoring with free style libre monitoring device (FSL-CGM) during and outside Ramadan period. We recorded DM or CVD-related emergency visit or hospitalisation, change in BMI, systolic and diastolic BP, lipids profile, e-GFR, HBA1c, and frequency of hypoglycemia during Ramadan fasting and not -fasting period. Results This is first study using CGM in CHD patients with diabetes who observe fast in Ramadan. Patients had a significantly higher incidence (3.2 ± 2.8 vs 1.1 ± 1.6 episodes, p = 0.033) and prolonged duration of hypoglycemia (117.8 ± 87.2, 49.1 ± 59.1 min p 0.022) during fasting compared to non-fasting respectively. No significant alteration was seen in BMI, SBP and DBP, lipid profile and renal function. There is a significant improvement in HBA1c during Ramadan. Conclusion We could not associate any adverse cardiovascular effects with fasting Ramadan in patients with stable CHD under optimal diabetes care. FSL-CGMS data showed higher frequency of hypoglycemia during Ramadan fasting. Studies with larger sample size are needed for further validation of these findings.

Isolated renal artery thrombosis is a rare disease that usually results from systemic embolization and seldom secondary to in-situ thrombosis.1 Management is driven by the clinical presentation, timing and location of the occlusion. Various management options include anticoagulation, systemic thrombolysis, catheter directed thrombolysis or surgery. Recently, ultrasound-enhanced catheter directed thrombolysis has been approved for the management of pulmonary embolism. In our case we have successfully managed isolated renal artery thrombus via ultrasound-enhanced catheter directed thrombolysis.

Objectives The DAR Global survey of Ramadan-fasting during the COVID-19 pandemic aimed to describe the characteristics and care in participants with type 2 diabetes (T2D) with a specific comparison between those < 65years and > 65 years. Methods Participants were consented to answer a physician-administered questionnaire following Ramadan 2020. Impact of COVID-19 on the decision of fasting, intentions to fast and duration of Ramadan and Shawal fasting, hypoglycaemia and hyperglycaemia events were assessed. Specific analysis comparing age categories of 65years were performed. Results Among the 5865 participants, 22.5% were > 65 years old. Concern for COVID-19 affected fasting decision for 7.6% ( > 65years) vs 5.4% ( 65 years old did not fast (28.8% vs 12.7%, 15 days and 12.6% had to break fast due to diabetes-related illness. The average number of days fasting within and post-Ramadan were 27 and 6 days respectively, regardless of age. Hypoglycaemia and hyperglycaemia occurred in 15.7% and 16.3% of participants respectively, with 6.5% and 7.4% requiring hospital care respectively. SMBG was performed in 73.8% of participants and 43.5% received Ramadan-focused education. Conclusion During the COVID-19 pandemic, universally high rates of Ramadan-fasting were observed regardless of fasting risk level. Glycemic complications occurred frequently with older adults requiring higher rates of acute hospital care. Risk stratification is essential followed by pre-Ramadan interventions, Ramadan-focused diabetes education and self-monitoring to reduce and prevent complications, with particular emphasis in older adults.

The COVID-19 pandemic has stretched healthcare resources and caused severe knock-on effects on patients with metabolic diseases worldwide. We encourage clinicians and patient-interest groups in the field of diabetes and metabolism to raise their voices to ensure adequate care and admission of patients.

Objectives Using a large nationally representative database, we aimed to examine risk factors for acute kidney injury (AKI) and its association with outcomes in patients undergoing percutaneous left atrial appendage closure (LAAC). Background Previous small-scale studies have reported poor outcomes with AKI following percutaneous LAAC. Methods We queried the Nationwide Readmission Database to identify LAAC procedures performed from 2016 to 2017. Multivariable logistic and linear regression models were used to identify risk factors for AKI and determine the association between AKI and clinical outcomes. The primary outcome of interest was in-hospital mortality. Results Of 20,703 patients who underwent LAAC during the study period, 1,097 (5.3%) had a diagnosis of AKI. Chronic kidney disease, non-elective admission, coagulopathy, weight loss, prior coronary artery disease, heart failure, diabetes mellitus, and anemia were independently associated with an increased risk of AKI after LACC. In patients undergoing LAAC, AKI was associated with an increased risk of in-hospital mortality (adjusted odds ratio [aOR], 16.01; 95% CI, 8.48-30.21), stroke/transient ischemic attack (aOR, 2.50; 95% CI, 1.69-3.70), systemic embolization (aOR, 3.78; 95% CI, 1.64-8.70), bleeding/transfusion (aOR, 1.96; 95% CI, 1.50-2.56), vascular complications (aOR, 3.53; 95% CI, 1.94-6.42), pericardial tamponade requiring intervention (aOR, 6.83; 95% CI, 4.37-10.66), index length of stay (adjusted parameter estimate, 7.46; 95% CI, 7.02-7.92), and 180-day all-cause readmissions (aOR, 1.43; 95% CI, 1.09-1.88). Conclusion AKI in the setting of LAAC is uncommon but is associated with poor clinical outcomes. Further studies are needed to determine if a similar association exists for long-term outcomes.

International audience; Up to 50% of the people who have died from COVID-19 had metabolic and vascular disorders. Notably, there are many direct links between COVID-19 and the metabolic and endocrine systems. Thus, not only are patients with metabolic dysfunction (eg, obesity, hypertension, non-alcoholic fatty liver disease, and diabetes) at an increased risk of developing severe COVID-19 but also infection with SARS-CoV-2 might lead to new-onset diabetes or aggravation of pre-existing metabolic disorders. In this Review, we provide an update on the mechanisms of how metabolic and endocrine disorders might predispose patients to develop severe COVID-19. Additionally, we update the practical recommendations and management of patients with COVID-19 and post-pandemic. Furthermore, we summarise new treatment options for patients with both COVID-19 and diabetes, and highlight current challenges in clinical management.

OBJECTIVES: The DaR Global survey was conducted to determine the impact of the COVID-19 pandemic on the intentions to fast and the outcomes of fasting in

Although the literature is limited, early evidence suggests that patients with chronic kidney disease, end-stage kidney disease, and kidney transplant recipients are at increased risk for severe COVID-19 disease and death. Hence, management should focus on both infection prevention and treatment. There is currently a lack of evidence and guideline recommendations on optimal management of immunosuppression in kidney transplant recipients with COVID-19 infection. This article focuses on the prevention and management of COVID-19 in patients with chronic kidney disease, patients with end-stage kidney disease on home hemodialysis and peritoneal dialysis, and kidney transplant recipients.

Background Ramadan fasting is regarded as a form of worship amongst Muslims. However, patients with a high risk of diabetic complications are advised to avoid fasting, as the practice is associated with significant impacts on several health factors for type 2 diabetic patients, including glycaemic control. Thus, a lack of focused education before Ramadan may result in negative health outcomes. Aim To evaluate the impact of a Ramadan-focused diabetes education programme on hypoglycaemic risk and other clinical and metabolic parameters. Methods A systematic literature search was performed using Scopus, PubMed, Embase, and Google Scholar to identify relevant studies meeting the inclusion criteria from inception. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and guidelines were followed when performing the search and identification of appropriate studies. Results Seventeen studies were included in this systemic review; five of them met the criteria to compile for a meta-analysis. The included studies were with various study designs, including randomised controlled trials, quasi-experimental and non-randomised studies. Overall, the results revealed a significant reduction of hypoglycemia risk (81% reduction) for fasting patients in intervention groups who received Ramadan-focused education compared with patients receiving conventional care (OR 0.19, 95% CI: 0.08-0.46). Moreover, HbA1c significantly improved amongst patients who received a Ramadan-focused diabetes education intervention, compared with those receiving conventional care. Conclusion Ramadan-focused diabetes education had a significant impact on hypoglycemia and glycaemic control, with no significant effect on body weight, blood lipids or blood pressure.

There is enough evidence that patient education and lifestyle modification has shown benefits in diabetes care, however the evidence is less for improving care of hypertension. Our study is the first in the UK to assess the impact of a structured hypertension education program in subjects with type 2 diabetes.Prospective randomised controlled study.From a diabetes clinic in a district and general hospital in UK 132 participants were equally randomised into intervention group and control group. Intervention included a once weekly education session for 4 weeks together with home blood pressure monitoring and dose changes in antihypertensives. Base line data was recorded with follow up after 3 and 6 months.More participants achieved target BP in the intervention group versus control. This difference appeared early at the 3rd months (48.8% versus 20.4% respectively, p = 0.007) and remained at the 6th month (58.1% versus 20.4% respectively, p 0.001). The change in number of pills was significantly lower in the intervention group. The mean increase in antihypertensive pills was 0.22 ± 0.48 (13 ± 30% increase) in the intervention group versus 0.62 ± 0.68 (41 ± 60% increase) in the routine group (p = 0.014), denoting less need to escalate treatment.We demonstrated that our structured education program has led to a significantly higher percentage of participants achieving the BP target, early after intervention, together with a significant reduction in the number of antihypertensive pills.

Since their inception in the commercial market in the mid-twentieth century, sulfonylureas (SUs) have remained a therapeutic option in the management of type 2 diabetes (T2D). Despite their established glucose-lowering effects, there is no consensus among global experts and modern guidelines regarding the priority of SUs in relation to other therapeutic options, given the lack of evidence that SUs are associated with a low risk of macrovascular events and excess mortality. However, findings from recent trials and real-time observations have resolved this contentious issue somewhat, albeit to varying degrees. The present consensus discusses the role of SUs in contemporary diabetes management in the Gulf Cooperation Council (GCC) countries. Regional experts from these countries gathered virtually to formulate a consensus following presentations of topics relevant to SU therapy with an emphasis on gliclazide, including long-term efficacy, cost, end-organ benefits, and side effects, based on up-to-date evidence. The present narrative review reflects the conclusions of this assembly and provides a platform upon which future guidelines for the use of SUs in the GCC can be tailored.

ORION, a prospective observational study, evaluated the safety and effectiveness of the second-generation basal insulin analog Gla-300 in people who fast during Ramadan. Adults (≥18 years) with T2DM who intended to fast for ≥15 days during Ramadan, had taken Gla-300 for ≥8 weeks before inclusion and intended to continue during Ramadan were enrolled in 11 countries (grouped by region; Table). Mean (SD) number of fasting days was 30.1 (3.2). Mean diabetes duration ranged from 7.9 to 13.5 years and ≥77.5% had moderate/low risk associated with fasting (investigator-assessed). Proportions of people with ≥1 severe and/or symptomatic documented hypoglycemia event were low for the overall population and in Groups 1-3; 1 severe hypoglycemia event was reported in pre-Ramadan. Glycemic control improved pre- to post-Ramadan in Groups 1-3 and Gla-300 dose adjustments were minimal. In Canada, 24% of people had ≥1 severe and/or symptomatic documented hypoglycemia event in Ramadan; there was no change in glycemic control, but pre-Ramadan HbA1c target achievement was high (30.4%). In this real-world study, people with T2DM who received Gla-300 and fasted for Ramadan generally had low incidence of hypoglycemia, with no severe events in Ramadan, and slightly improved glycemic control; results from Canada varied, possibly due to longer fasting hours. Disclosure M. Hassanein: Advisory Panel; Self; Novo Nordisk A/S. Speaker’s Bureau; Self; Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. M.A. Buyukbese: Consultant; Self; Sanofi. R. Malek: None. V. Pilorget: Employee; Self; Sanofi. M. Naqvi: Employee; Self; Sanofi. B. Berthou: None. I. Shaltout: Advisory Panel; Self; Sanofi, Novartis, MSD, Astra Zeneca, Novo Nordisk, Lilly, Servier and Abbott. Speaker’s Bureau; Self; Sanofi, Novartis, MSD, Astra Zeneca, Novo Nordisk, Lilly, Servier and Abbott. R. Sahay: Advisory Panel; Self; Boehringer Ingelheim, Dr. Reddy’s Laboratories, Eli Lilly and Company, Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Funding Sanofi; World Health Organization (CTRI/2019/02/017636)

Acute kidney injury has been reported in as many as 29% of COVID-19 patients. Reported risk factors include elevated baseline serum creatinine, elevated blood urea nitrogen, acute kidney injury, proteinuria, and hematuria. Suspected causes include sepsis and acute tubular necrosis resulting from renal hypoperfusion, cytokine release syndrome, direct viral invasion, renal medullary hypoxia secondary to alveolar damage, rhabdomyolysis, and cardiorenal syndrome due to viral myocarditis.

OBJECTIVES This study sought to determine the impact of baseline chronic kidney disease (CKD) on in-hospital outcomes of transcatheter mitral valve repair with MitraClip (MC). BACKGROUND MC is now an established treatment in high surgical risk patients. However, limited data are available on outcomes of MC in patients with baseline renal dysfunction. METHODS The authors used data from January 2014 to December 2017 National Readmission Database to identify all patients ≥18 years of age who underwent MC. International classification of diseases (ICD)-9 and ICD-10 codes were used to identify patients with no-CKD, CKD (without chronic dialysis), or end-stage renal disease (ESRD) on dialysis. Multivariable logistic regression models were constructed using generalized estimating equations to examine in-hospital outcomes. RESULTS Of 13,563 patients undergoing MC, 8,935 (65.8%) had no-CKD, 4,152 (30.6%) had CKD, and 476 (3.5%) had ESRD. ESRD patients compared to CKD and no-CKD had significantly higher mortality (7.2% vs. 2.5% vs. 2.0%; p

ORION was a prospective, observational study evaluating the safety and effectiveness of the second-generation basal insulin analog Gla-300 in people with type 2 diabetes (T2DM) who fast during Ramadan. Adults with T2DM who intended to fast for ≥15 days during Ramadan, had taken Gla-300 for ≥8 weeks prior to inclusion, and intended to continue its use during Ramadan were enrolled in 11 countries. During Ramadan, Gla-300 treatment was adjusted as per routine practice by the treating physician. Overall, the majority of people (402 [85%]) fasted for the entire Ramadan period and 10.8% fasted for ≥25 days but with at least one missed day. Mean (SD) age was 54.4 (11.0) years, 51.7% were male, BMI was 29.7 (5.3) kg/m2, and duration of diabetes was 10.7 (7.0) years. Risks of diabetes-related complications associated with fasting were assessed by physicians according to IDF-DAR fasting risk category; risk was low/moderate in 82.8%, high in 14.3%, and very high in 2.9% of people. The proportion of people with ≥1 severe and/or documented symptomatic (SMPG ≤70 mg/dL) hypoglycemia event was low (2.2% [event rate: 0.021 per participant-month (PPM)] in pre-Ramadan, 2.6% [0.039 PPM] in Ramadan and 0.2% in post-Ramadan [0.003 PPM]). Overall, 0.8% (0.005 PPM) of participants experienced severe and/or documented symptomatic hypoglycemia at SMPG

Background Fasting in the holy month of Ramadan is among the five pillars of Islam and is considered as a religious obligation by the Muslim population. People with diabetes observing the practice of fasts are at a higher risk of complications such as hypoglycaemia, hyperglycaemia and ketoacidosis due to changes in eating patterns and circadian rhythms. With the objective of mitigating these complications, the South Asian Health Foundation (UK) has developed the present guidelines based on robust evidence derived from epidemiological studies and clinical trials. Methods We have highlighted the role of pre-Ramadan risk stratification and counselling by healthcare professionals with emphasis on the need for advice on adequate dietary and fluid intake, blood glucose monitoring and awareness of when to break the fast. Results We reviewed the current literature and have given clinically-relevant recommendations on lifestyle modifications and glucose-lowering therapies such as metformin, sulphonylureas, dipeptidyl peptidase-4 inhibitors, sodium glucose co-transporter-2 inhibitors, thiazolidinediones, glucagon-like peptide-1 receptor agonists and insulin. Conclusions An individualised patient-centric treatment plan is essential to not only achieve optimal glycaemic outcomes but also enable people with diabetes to observe a risk-free month of fasting during Ramadan.

Aims To explore the real-world safety and effectiveness of gliclazide modified release (MR) in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan. Methods DIA-RAMADAN (NCT04132934) was a prospective, international, observational study conducted in nine countries. Patients >18 years of age with T2DM (N = 1244) were examined at an inclusion visit (V0) occurring 6–8 weeks before the start of Ramadan. Patients received a diary to report treatment changes, hypoglycaemic events (HEs), and other adverse events. Gliclazide MR was taken once daily for 14–18 weeks. A second visit (V1) was conducted 4–6 weeks after the end of Ramadan. The primary endpoint was the proportion of patients reporting ≥1 symptomatic HE. Changes in HbA1c, fasting plasma glucose (FPG), and body weight were secondary endpoints. Results The proportion of patients reporting ≥1 symptomatic HE during Ramadan was low (2.2%) with no reported severe HEs. There was a significant reduction in HbA1c (−0.3%), FPG (–9.7 mg/dL), body weight (−0.5 kg) and body mass index (−0.2 kg/m2) between V0 and V1 (p Conclusions Patients with T2DM treated with gliclazide MR during Ramadan have a low risk of hypoglycaemia and maintain glycaemic control and weight while fasting.

Background The importance of influenza is increasing mainly because of the appearance of novel pandemic strains such as swine and avian. Each year, influenza has spread around the world causing about 250,000–500,000 deaths and more than 5 million cases of severe illness. The objective is as follows: evaluating the outcomes of patients with influenza A (H1N1) virus in relation to certain TNF-308, IL6, and IL8 polymorphisms and identifying the associated factors with the severe outcome. Subject and methods This is a case–control study. The cases were patients confirmed by real-time polymerase chain reaction (RT-PCR) to be influenza A (H1N1) virus infected. The controls were healthy individuals. Medical history and outcome of the disease was registered. In all study participants, polymorphisms of TNF rs1800629, IL6 rs18138879, and IL8 rs4073; odds ratio (OR); and the 95% confidence interval (95% CI) were calculated. Results Infection with influenza A (H1N1) virus was associated more with the following genotypes: TNF-308 AA (OR = 4.041; 95% CI = 1.215–13.4) and IL8 AA (OR = 3.273; 95% CI = 1.372–7.805). According to our study results, HCV (OR = 3.2, 95% CI 1.2–8.5), renal disease (OR = 3.4, 95% CI 0.9–13.6), cancer (OR = 3.1, 95% CI 0.3–31.1), TB (OR = 8.4, 95% CI 1.8–39.7), ICU (OR = 2.9, 95%1.2–7.1), and mortality (OR = 7.9, 95% CI 0.9–67.4) are considered as risk factors for influenza A (H1N1)-infected patients. Conclusions Our findings concluded that TNF-308 (AA) and IL8 (AA) polymorphisms may increase the susceptibility to be infected with H1N1influenza virus.

Background Drug reaction with eosinophilia and systemic symptoms (DRESS) is a severe hypersensitivity drug reaction involving the skin and multiple internal organ systems. The symptoms typically present with fever and skin rash, and rapidly progress to multiple organ failures. Vancomycin is a rare drug to cause DRESS syndrome with 23 cases reported to date. Case presentation We described a case of a 39 year-old man who was treated with vancomycin for osteomyelitis of the foot. The patient subsequently developed acute respiratory distress syndrome (ARDS) followed by rash and acute interstitial nephritis. These symptoms were improved by withdrawal of vancomycin and a pulsed corticosteroid regimen. According to the European Registry of Severe Cutaneous Adverse Reaction Criteria (RegiSCAR) (Kardaun et al, British Journal of Dermatology, 169:1071-1080, 2013), the probability of vancomycin induced DRESS syndrome was scored as “Definite”. A literature search of vancomycin induced DRESS syndrome was also performed and the overall pulmonary involvement was estimated as 5%. To our knowledge, this was the first case reported with pulmonary involvement as the initial symptom. Conclusion This is the first case to report pulmonary manifestation as the initial symptom in vancomycin induced DRESS syndrome. Prompt recognition of this entity can expedite proper treatment and hasten recovery. Electronic supplementary material The online version of this article (10.1186/s12890-017-0564-6) contains supplementary material, which is available to authorized users.