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Phawit Norchai,1 Thipaporn Tharavanij,2– 5 Picha Suwannahitatorn,6,7 Thammanard Charernboon1,8 1Department of Clinical Epidemiology, Faculty of Medicine, Thammasat University, Pathumthani, Thailand; 2Endocrinology and Metabolism Unit, Department of Medicine, Faculty of Medicine, Thammasat University, Pathumthani, Thailand; 3Diabetes and Metabolic Syndrome Research Unit, Faculty of Medicine, Thammasat University, Pathumthani, Thailand; 4Center of Excellence in Applied Epidemiology, Faculty of Medicine, Thammasat University, Pathumthani, Thailand; 5Thammasat University-Center of Excellence for Diabetic Foot Care, Thammasat University Hospital, Pathumthani, Thailand; 6Department of Parasitology, Phramongkutklao College of Medicine, Bangkok, Thailand; 7Biostatistics Unit, Office of Research Development Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand; 8Department of Psychiatry, Faculty of Medicine, Thammasat University, Pathumthani, ThailandCorrespondence: Phawit NorchaiDepartment of Clinical Epidemiology, Faculty of Medicine, Thammasat University, 12120, ThailandTel +66 29269757Email dr.arkanay@gmail.comBackground: Metabolic syndrome is diagnosed using clinical and laboratory data. Electro interstitial scan (EIS) is a rapid and noninvasive screening. It measures and calculates the parameters to reflect hypertension, sympathetic activity, stiffness of the arteries, body fat composition, leptin and insulin resistance. Metabolic syndrome will be diagnosed if calculated score ≥ 10 CU.Purpose: To evaluate the accuracy, validity and appropriate cut-off score to diagnose metabolic syndrome.Materials and Methods: A cross-sectional study was conducted using the population-based approach. Metabolic syndrome was diagnosed according to the modified National Cholesterol Education Program (NCEP ATP III) and International Diabetes Federation (IDF) criteria. The appropriate cut-off score to diagnose metabolic syndrome by instrument was determined.Results: A total of 253 participants were enrolled with mean age of 40.06± 6.33 years, and 64.43% (163/253) were female. Metabolic syndrome was diagnosed among 123 (48.62%) and 104 (41.11%) patients according to the NCEP ATP III and IDF criteria, respectively. The diagnostic indices of metabolic syndrome score ≥ 10 CU had a sensitivity of 23.6% and 27.9%, a specificity of 100% and area under ROC of 0.62 and 0.64, according to the NCEP ATP III and IDF criteria, respectively. The best cut-off level of metabolic syndrome score was ≥ 9 CU with a sensitivity of 79.67% (95% CI, 71.5– 86.4%) and 88.46% (95% CI, 80.7– 93.9%), a specificity of 96.92% (95% CI, 92.3– 99.2%) and 93.29% (95% CI, 88.0– 96.7%) and area under ROC 0.89 (95% CI, 0.85– 0.93) and 0.92 (95% CI, 0.88– 0.95), respectively, according to the NCEP ATP III and IDF criteria.Conclusion: Screening of metabolic syndrome using ES TECK in a Thai population demonstrated inadequate accuracy when using metabolic syndrome score ≥ 10 CU. We recommend using a metabolic syndrome score ≥ 9 CU to provide the best accuracy. This instrument is safe, fast and easy to use for metabolic syndrome screening.Keywords: diagnostic, accuracy, validity, EIS, ES TECK

Background: Inadequate diabetes self-management leads to foot infections and lower extremity amputations. Effective self-care, supported by nurse-provided information, is crucial, particularly in foot care. However, the current approach in Thailand focuses more on what nurses want patients to know rather than addressing patients' actual needs. Consequently, nurses might misunderstand their patients' perspectives. Hence, nurses need to grasp patients' needs for successful foot care behavior., Objective: This study aimed to explore the needs of patients with diabetes regarding the prevention and treatment of foot complications., Methods: The study employed a qualitative descriptive design. Thirty participants classified as high risk for foot ulcers were purposively selected from Thailand's university hospitals. Focus group discussions were used for data collection between June and July 2021. Verbatim transcription and content analysis were carried out for data analysis., Results: Four emergent themes highlighted patients' needs: 1) information-giving, 2) proactive foot screening with foot-care affirmation, 3) foot care services, and 4) relieving foot burdens and limb loss., Conclusion: Nurses should change their mindset to care for and continually understand patients' needs. This involves adapting educational strategies like the teach-back method and coaching while providing skill training. Offering diverse service platforms, both online and onsite education programs and counseling, is essential. Additionally, ensuring accessibility and affordability, such as establishing after-hours clinics and supplying foot care toolkits, remains crucial., Competing Interests: The authors declared that there is no conflict of interest., (© The Author(s) 2023.)

Monitoring the level of glycated hemoglobin (HbA1c) has become the gold standard measure for diabetes mellitus (DM) diagnosis and control, used in conjunction with fasting blood glucose (FBG) and oral glucose tolerance test. This study aimed to investigate the applicability of a newly developed nanoparticle-based electrochemical sensor-multiwalled nanotubes incorporated with gold nanoparticles (POCT-HbA1cMWCNTs/AuNPs)-used as a routine point-of-care test (POCT) for detection of HbA1c for the diagnosis of DM. Finger-prick and venous blood samples were collected from 108 DM and 98 non-DM subjects to determine HbA1c and total hemoglobin by POCT-HbA1cMWCNTs/AuNPs compared with the standard HPLC method. The performance of the POCT-HbA1cMWCNTs/AuNPs was evaluated using the standard cut-off HbA1c level of >6.5%. The test's sensitivity, specificity, positive predictive value, and negative predictive value were 100.00%, 90.32%, 87.23%, and 100.00%, respectively. The probability of DM diagnosis in a subject with HbA1c >6.5% (positive predictive value) was 87.23% (82/94). The accuracy of the POCT-HbA1cMWCNTs/AuNPs was 94.18%, with a %DMV (deviation from the mean value) of 0.25%. The results indicate satisfactory assay performance and applicability of the POCT-HbA1cMWCNTs/AuNPs for diagnosis of DM using the cut-off criteria of HbA1c >6.5., Competing Interests: No authors have competing interests., (Copyright: © 2023 Boonprasert et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Medical nutritional therapy is vital in patients with diabetes. A low glycemic index (GI) is generally advised in the management of women with gestational diabetes mellitus (GDM). However, the efficacy of this advice has not been systematically examined. The purpose of this study was to determine whether recommending a low to moderate GI rice (RD43 rice; GI = 56.9) in women with GDM would reduce the number of women requiring insulin, compared with rice of high GI (Thai Hom Mali [THM] rice; GI = 80.1)., Methods: Ninety-six participants with GDM were randomly assigned to receive either RD43 rice or THM rice., Results: The mean ± SD ages in the RD43 and THM groups were 33.1 ± 13.1 and 33.6 ± 4.1 years, respectively. The mean gestational ages at the sampling in the RD43 and THM groups were 23.3 ± 5.9 and 23.5 ± 5.4 weeks. Both groups had comparable baseline characteristics, including age, gestational age, body mass index prior to pregnancy and at enrollment, baseline postprandial (oral glucose tolerance test) plasma glucose level, and hemoglobin A 1c . Of the 48 women assigned to the RD43 group, 3 (6.3%) required insulin; in the THM group, 11 (22.9%) met the criteria for insulin therapy (P = 0.017). However, 10 of these 11 women were able to avoid insulin use by changing to the low to moderate GI rice., Conclusion: Using a low to moderate GI rice in GDM effectively reduced the number of patients requiring insulin therapy. Thai Clinical Trials Registry ID: TCTR20210524007., Competing Interests: Declaration of Interest The authors have indicated that they have no conflicts of interest with regard to the content of this article., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: The coronavirus disease (COVID-19) outbreak in Bangkok led to a shortage of hospital capacity, and a home isolation system was set up. We described the process of diabetes self-management education and support (DSMES) and glycemic management via telemedicine, along with outcomes in home-isolated patients with COVID-19 infection., Methods: A retrospective chart review of glucose values, insulin and corticosteroids use, and outcomes was performed., Results: A volunteer group of 21 endocrinologists and 21 diabetes educators/nurses formed the consultation team. Patients with diabetes or at high-risk of diabetes and receiving corticosteroids were referred by primary volunteer physicians. Glucometers and related supplies, and insulin were donated, and delivered via same-day delivery services. A chat group of an individual patient/their caregiver, diabetes educator, endocrinologist, and primary physician was formed (majority via LINE ® platform) to assess the patient's clinical status and need. Real-time virtual DSMES sessions were performed and treatments were adjusted via smartphone application or telephone. There were 119 patients (1,398 service days), mean (SD) age 62.0 (13.6) years, 85.7% had a history of type 2 diabetes, and 84.0% received corticosteroids. Insulin was used in 88 patients; 69 of whom were insulin-naïve. During the first 10 days, there were 2,454 glucose values. The mean glucose level on day 1 was 280.6 (122.3) mg/dL, and declined to 167.7 (43.4) mg/dL on day 10. Hypoglycemia occurred in 1.4% of the values. A majority of patients (79.5%) recovered at home., Conclusion: Diabetes care and DSMES delivered via telemedicine to patients on home isolation during COVID-19 pandemic was safe and effective., (© 2022 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.)

Thunbergia laurifolia (TL) has been traditionally used as an antidote and an antipyretic drug by folk healers for centuries in Thailand. Rosmarinic acid (RA) is major compound in TL extract and has attracted great interest due to its potential broad pharmacological effects. Herein, the permeability of RA was investigated in TL extract and as a pure compound in a Caco-2 cell model by using high-performance liquid chromatography with a photodiode array detector (HPLC-PDA). The results reveal that the apparent permeability coefficient ( P app ) values of RA in TL extracts and pure RA significantly increased after deconjugation by β-glucuronidase/sulfatase enzymes. Our findings exhibit possible saturable biotransformation of RA and/or membrane transport while penetrated through Caco-2 cells. The cumulative amounts of RA as pure compounds and in TL extracts increased with the exposure time, and the efflux ratio (ER) was 0.27-1.14. RA in the TL extract has a similar absorption in the conjugated form and in the pure compound. The intestinal absorption of them is through passive diffusion. Therefore, our findings conclude that the intestinal transport of RA in TL extracts was mainly penetrated as conjugated forms with glucuronic acid and/or sulfate across Caco-2 cells and transported via passive diffusion.

Aims/introduction: There is a lack of current information regarding young-onset diabetes in Thailand. Thus, the objectives of this study were to describe the types of diabetes, the clinical characteristics, the treatment regimens and achievement of glycemic control in Thai patients with young-onset diabetes., Materials and Methods: Data of 2,844 patients with diabetes onset before 30 years-of-age were retrospectively reviewed from a diabetes registry comprising 31 hospitals in Thailand. Gestational diabetes was excluded., Results: Based on clinical criteria, type 1 diabetes was identified in 62.6% of patients, type 2 diabetes in 30.7%, neonatal diabetes in 0.8%, other monogenic diabetes in 1.7%, secondary diabetes in 3.0%, genetic syndromes associated with diabetes in 0.9% and other types of diabetes in 0.4%. Type 1 diabetes accounted for 72.3% of patients with age of onset <20 years. The proportion of type 2 diabetes was 61.0% of patients with age of onset from 20 to <30 years. Intensive insulin treatment was prescribed to 55.2% of type 1 diabetes patients. Oral antidiabetic agent alone was used in 50.8% of type 2 diabetes patients, whereas 44.1% received insulin treatment. Most monogenic diabetes, secondary diabetes and genetic syndromes associated with diabetes required insulin treatment. Achievement of glycemic control was identified in 12.4% of type 1 diabetes patients, 30% of type 2 diabetes patients, 36.4% of neonatal diabetes patients, 28.3% of other monogenic diabetes patients, 45.6% of secondary diabetes patients and 28% of genetic syndromes associated with diabetes patients., Conclusion: In this registry, type 1 diabetes remains the most common type and the prevalence of type 2 diabetes increases with age. The majority of patients did not achieve the glycemic target, especially type 1 diabetes patients., (© 2021 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.)

Background: Relative adrenal insufficiency (RAI) is frequently found in patients with liver cirrhosis, especially in critically ill conditions. However, the prognostic impact of RAI in non-critically ill cirrhosis remains controversial. The aim of the present study was to assess the prevalence of RAI and its prognostic implication in non-critically ill cirrhotic patients., Methods: From December 2015 to November 2017, hospitalised non-critically ill cirrhotic patients admitted with hepatic decompensation were prospectively enrolled in this study. Within 24 hours after admission, 250 mcg ACTH stimulation test was performed. RAI was defined as an increase in serum cortisol <9 mcg/dL in patients with basal serum cortisol <35 mcg/dL. Clinical outcomes were evaluated during admission and at 30-, 90-day visits., Results: One hundred and fifteen patients were included (66% male, mean age 59.9 ± 16 years, mean MELD 16.1 ± 6.8, Child A/B/C 15.7%/53.9%/30.4%). The main indications for admission were bacterial infection (44.6%) and portal hypertension-related bleeding (19.1%). RAI was detected in 35 patients (30.4%). Patients with RAI had higher Child-Pugh score (9.4 ± 1.9 vs 8.0 ± 1.7, P < .01), and MELD scores (18.3 ± 5.9 vs 15.1 ± 6.9, P = .02). The in-hospital, 30-, and 90-day mortality rates were 9.6%, 20.9%, and 26.1%, respectively. There was no significant difference in the incidence of nosocomial infection, severe sepsis, septic shock, HRS, and mortality rates between patients with and without RAI. By multivariate analysis, bacterial infection on admission (HR 3.13, P < .01) and acute-on-chronic liver failure (HR 4.98, P < .001) were independent predictors of 90-day survival., Conclusions: RAI is found in about one-third of hospitalised non-critically ill cirrhotic patients and is associated with the severity of cirrhosis. However, the presence of RAI has no influence on short-term outcomes., (© 2021 John Wiley & Sons Ltd.)

Aims/introduction: The Thai Type 1 Diabetes and Diabetes Diagnosed Before Age 30 Years Registry, Care and Network was established in 2014 and involved 31 hospitals. The objective of the registry was to evaluate glycemic control and complications of patients with type 1 diabetes., Materials and Methods: Patients' demographics, clinical data, frequencies of daily self-monitoring of blood glucose (SMBG), glycemic control and complications were collected., Results: Among the 1,907 type 1 diabetes patients, the mean age was 21.2 ± 11.3 years. The mean glycated hemoglobin level was 9.35 ± 2.41%, with significant variations among age groups (P < 0.001). Conventional insulin treatment and intensive insulin treatment were used in 43 and 57% of patients, respectively. Mean glycated hemoglobin levels were significantly higher in patients treated with conventional insulin treatment compared to those treated with intensive insulin treatment (9.63 ± 2.34 vs 9.17 ± 2.46%, P = 0.002). Compared to the conventional insulin treatment group, significantly more patients in the intensive insulin treatment group achieved good glycemic control (P < 0.001), and fewer had diabetic retinopathy (P = 0.031). The prevalence of microvascular complications increased significantly with age (P < 0.001). Multivariate analysis showed good glycemic control to be associated with age 25 to <45 years, intensive insulin treatment with SMBG three or more times daily and diabetes duration of 1 to <5 years., Conclusions: Most Thai type 1 diabetes patients were not meeting the recommended glycemic target. As a result of this study, the national program to improve the quality of diabetes treatment and education has been implemented, and the results are ongoing., (© 2020 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.)

Background and Aim: Atractylodes lancea (AL) has been demonstrated in a series of studies to be a potential candidate for the treatment of cholangiocarcinoma. The aim of the current study was to evaluate the safety and pharmacokinetics of the capsule formulation of the standardized AL extract in healthy Thai participants., Experimental Procedure: Forty-eight healthy Thai participants who fulfilled the inclusion and had none of the exclusion criteria were allocated to two study groups. The group 1 participants were randomized to receive a single oral dose of 1,000 mg of AL or placebo (20:4 participants). The group 2 participants were randomized to receive daily oral doses of 1,000 mg AL or placebo daily for 21 days (20:4 participants). Safety and tolerability of the two AL regimens were monitored. Blood samples were collected for measurement of atractylodin concentrations by HPLC and pharmacokinetic analysis was performed using model-dependent and model-independent analysis., Results and Conclusion: The AL extract was well tolerated in both groups. Atractylodin was rapidly absorbed but with low systemic exposure and residence time. There was no difference in the pharmacokinetic parameters of atractylodin following a single or multiple dosing, suggesting the absence of accumulation and dose-dependency in human plasma after continuous dosing for 21 days. The information on human pharmacokinetics of AL, when given as capsule formulation of the standardized extract, would assist in further dose optimization in cholangiocarcinoma patients with the defined pharmacokinetic-pharmacodynamic relationship., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2021 Center for Food and Biomolecules, National Taiwan University. Production and hosting by Elsevier Taiwan LLC.)

Objective: A randomized, double-blinded, crossover, placebo controlled trial was conducted to evaluate the efficacy and safety of 0.075% capsaicin lotion for treating painful diabetic neuropathy (PDN)., Patients and Methods: PDN subjects were randomized to receive 0.075% capsaicin/placebo for 8 weeks, then crossing over to the other treatment after a 4-weeks washout period. Primary endpoint was the change in visual analog scale score of pain severity. Secondary outcomes were score changes in Neuropathic Pain Scale, short-form McGill Pain Questionnaires, and proportions of patients with pain score reductions of 30% and 50%, and adverse events., Results: A total of 42 subjects were enrolled, 27 completed at least an 8-week treatment period. Intention-to-treat analysis showed no significant improvement in pain control with capsaicin lotion compared with placebo for all pain measures and proportion of patients who had 30% or 50% pain relief, respectively. Per protocol analysis were consistent. Capsaicin lotion was well tolerated but local skin reactions were common., Conclusion: In patients with PDN, the efficacy of 0.075% capsaicin lotion was similar to placebo but was well tolerated. More work is needed to assess different capsaicin formulations., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research., Methods: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important)., Results: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively)., Conclusions: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.

Purpose: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions., Methods: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test., Results: The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001)., Conclusions: The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

Background: The study of metabolic syndrome after delivery and its relationship to gestational diabetes (GDM) in Thai is lacking., Objective: To compare the prevalence and risk factors of metabolic syndrome after delivery in GDM and normal pregnant Thai women., Material and Method: A case-control study was performed at Thammasat University Hospital. Women with previous history of GDM (n = 56) and normal pregnant women (n = 51) delivered during 2007-2013 were enrolled. All of them underwent metabolic profile evaluation and 75 gm oral glucose tolerance test in 2013-2014. Risk factors of metabolic syndrome were assessed by logistic regression model., Results: Women were recruited a mean of 2.97±)1.15 years after delivery. Compared to the control group, the mean current age, median body mass index (BMI) before pregnant, current BMI, waist/height ratio and systolic blood pressure were significantly higher in GDM group. Metabolic syndrome was more in the GDM group (26.8% (15/56) vs. 7.8% (4/51), OR 4.3, 95% CI: 1.32-13.99). Only a BMI ≥25 kg/m2 before index pregnancy was a significant independent factor for this condition (OR 7.18, 95% CI 1.79-28.80; p = 0.005). After delivery, GDM group had more insulin resistance, assessed by HOMA-IR, less insulin sensitivity assessed by Masuda index and QUICKI score and less insulin secretion assessed by HOMA-B, comparing to control group without metabolic syndrome., Conclusion: Previously diagnosed GDM women have higher prevalence of metabolic syndrome after delivery. Obesity before pregnant is a strong independent risk factor for this condition.

In mice, undercarboxylated osteocalcin (ucOC) improves beta-cell function and insulin sensitivity through adiponectin. In humans, levels of total osteocalcin (OC) and ucOC were negatively correlated with insulin resistance (IR) indices in patients with type 2 diabetes. Whether ucOC plays a role in glucose homeostasis and whether its effect is mediated through adiponectin during pregnancy is unclear. Serum levels of total OC, ucOC, and adiponectin were measured in 130 pregnant women with varying degrees of IR [gestational diabetes mellitus (GDM), n = 74 and non-GDM, n = 56]. In all participants, total OC and ucOC levels were positively correlated with HOMA-IR and HOMA-%B, and negatively correlated with QUICKI. In contrast, adiponectin levels were negatively correlated with HOMA-IR and positively correlated with QUICKI (P < 0.01, both). However, neither total OC nor ucOC was associated with adiponectin. Although none of these markers could help distinguish women with and without GDM, total OC and ucOC levels were significantly higher in non-GDM women who had 1 abnormal OGTT value than those who had all normal OGTT values. Total OC and ucOC levels were significantly correlated with insulin secretion and IR indices, but not adiponectin levels, in pregnant women. Changes in OC might be a sensitive response to increased IR during pregnancy, which was not mediated through adiponectin.

Objective: To compare maternal and neonatal complications ofgestational diabetes mellitus (GDM) between conservative and systematic management., Material and Method: This retrospective cohort study was conducted at Thammasat University Hospital, Thailand. GDM subjects who were diagnosed and treated from October 2004 to March 2007 were classified as the conservative management group (CMG). The participants who were diagnosed and treated from April 2007 to September 2009 were classified as the systematic management group (SMG). SMG was ambulatory-managed per standard protocol by a multidisciplinary team (physician, diabetes nurse case manager nutritionist and pharmacologist)., Results: There were 87 and 118 subjects in CMG and SMG, respectively. Mean age and body mass index before pregnancy in CMG and SMG were not statistical different. Oral glucose tolerance tests (50 and 100 gram) were similar in both groups. The prevalence of GDM A2 was 57.5 and 55.1% in CMG and SMG, respectively. Mean gestational age at DM clinic consultation and number of hospital admission of SMG was less than CMG (p < 0.001). Neonatal hypoglycemic episode in SMG was less than CMG (1.7 vs. 10.3; p = 0.007). Postpartum 75-gram glucose tolerance test appointments and percentages of underwent in SMG were more than CMG (p < 0.001). Other composite maternal and neonatal outcomes were not different in either group., Conclusion: Systematic management by a multidisciplinary team conducted according to a practical guideline has the benefit of neonatal hypoglycemia reduction and hospital admission included postpartum DM surveillance increments.

Background: Water extract from Malvastrum coromandelianum (Linn.) Garcke (MC) has been shown to have glucose lowering effect, short- and long-term safety in animal studies. A preliminary study in human reveals safety and its potential use as an adjunctive treatment to antihyperglycemic medications., Objective: To investigate the glycemic-lowering efficacy ofMC in type 2 diabetes subjects., Material and Method: A multicenter randomized, double-blind, placebo-controlled trial was conducted. Seventy-one diabetes subjects, who were treated with either diet control or single oral anti-diabetic drug (sulphonylurea or biguanide) with HbA1C between 6.5-9%, were recruited. Subjects were randomized to take MC tablets in a total dose of 1,200 mg/day or placebo for 12 weeks. Clinical parameters, glycemic control, HOMA-IR and HOMA-β were assessed., Results: Both MC (n = 34) and placebo (n = 37) groups had comparable baseline characteristics with a mean baseline HbA1C of 7.6 ± 0.82 vs. 7.5 ± 0.8%, respectively. During the study, HbA1C did not differ statistically after 4, 8 and 12 weeks of treatment (7.7 ± 0.97 vs. 7.6 ± 1.0, 7.9 ± 1.09 vs. 7.8 ± 1.03 and 7.8 ± 1.1 vs. 7.6 ± 1.1%, respectively). The body weight, insulin resistance and insulin secretion were also similar between groups (p > 0.05). No episode of hypoglycemia was reported., Conclusion: MC in a dosage of 1,200 mg/day does not have glucose lowering efficacy in type 2 diabetes.

Objective: To assess the incidences and outcomes of hyperglycemic crises., Material and Method: A retrospective study of diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) in adults with type 1 or type 2 diabetes mellitus (DM) admitted to Thammasat Hospital between 2006 and 2010 was performed. Incidences, precipitating causes, clinical and laboratory characteristics, and treatment outcomes of hyperglycemic crises were obtained via medical record review Multivariate logistic regression analysis was used to determine predictors for mortality., Results: Eighty-three patients were eligible and included. The mean age was 54.9 +/- 17.7 years old. Most subjects had type 2 DM (86.7%). The 5-year incidence of hyperglycemic crises was 7.46%. Diabetic ketoacidosis occurred more frequently than HHS (4.67% vs. 1.71%). During the hyperglycemic episodes, the mean plasma glucose level on admission was 741.3 +/- 320.8 mg/dL. Infections were the most common precipitating factor [61/83 (73.5%)], followed by non-compliance with treatments [35/83 (42.2%)]. Treatment complications included recurrent hyperglycemia (69.9%), hypokalemia (48.2%), hypernatremia (21.7%), and hypoglycemia (15.7%). The overall mortality rate of hyperglycemic crises was 8.4% (5.8% in DKA, 15.8% in HHS and 8.3% in the overlap of both conditions). The most common causes of death were infections [5/7 (71.4%)]. By multivariate analysis, serum sodium level on admission was independently associated with mortality (adjusted odds ratio 1.08, 95% CI 1.01-1.16, p = 0.03)., Conclusion: Hyperglycemic crises were common in the authors' setting. Diabetic ketoacidosis occurred more frequently but had a lower mortality rate than HHS. Complications from hyperglycemic crisis treatment could be prevented by close monitoring, while high serum sodium level on admission was a predictor for mortality. Strategies to prevent infections and improve treatment compliance are needed to reduce the incidence of hyperglycemic crises among patients with DM.

Retinol-binding protein 4 (RBP4) is an adipokine proposed to be specifically associated with insulin resistance (IR). We examined whether serum levels of RBP4 were associated with IR in pregnancy. One hundred seventy-two women with gestational diabetes mellitus (GDM) and 361 pregnant Thai women who did not have GDM but had a positive 50-g glucose challenge test result (plasma glucose level was ≥7.2 mmol/L after 1 hour) were enrolled. We measured fasting serum levels of RBP4 and assessed IR at a 100-g oral glucose tolerance test. We found a higher degree of IR in the GDM group compared with the non-GDM group, but serum RBP4 levels between the 2 groups were not different. Retinol-binding protein 4 levels were associated with serum triglyceride levels but were not associated with the degree of IR assessed by homeostasis model assessment or quantitative insulin sensitivity check index. Our results suggest that serum RBP4 levels in pregnancy are not associated with IR., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objectives: To compare lipid-lowering efficacy and high sensitive C-reactive protein (hsCRP) level between morning and evening simvastatin administration in hyperlipidemia subjects., Material and Method: A randomized double blind controlled trial was conducted in 52 dyslipidemia subjects. A group of twenty five subjects received 10 mg simvastatin in the morning and placebo in the evening. The other group of twenty seven subjects received vice versa. Serum lipid profiles were evaluated every 4 weeks for the total course of 12 weeks. High sensitive CRP was measured at the beginning and the end of the study., Results: Baseline LDL levels were similar in both groups (p = 0.95). The evening simvastatin group had significantly less low density lipoprotein level (LDL) than the morning group at 4 weeks (112 +/- 26.1 mg/dl vs. 136.3 +/- 32 mg/dl, p = 0.001) and 8 weeks after treatment (109.7 +/- 28 mg/dl vs. 129.5 +/- 27 mg/dl, p = 0.006). Difference in LDL after 12th week between two groups was not significant (p = 0.23). Triglyceride and HDL level were not different in both groups. Only evening simvastatin administration could significantly decrease hsCRP (p = 0.03)., Conclusion: Simvastatin should be taken in the evening. Although lipid profiles were not statistically different in morning and nighttime simvastatin, the inflammatory marker (hsCRP level) is significantly reduced as a result of evening simvastatin administration.

OBJECTIVE To evaluate if baseline serum lipids are associated with islet graft survival in type 1 diabetes islet transplant (ITx) recipients. RESEARCH DESIGN AND METHODS Baseline fasting lipid profile was collected from 44 ITx recipients. Comparisons were performed between subjects below and above the median values of each lipid fraction. Differences in outcomes were compared by Kaplan-Meier curves and Cox regression analysis. RESULTS Subjects with baseline fasting plasma triglycerides and VLDL cholesterol above the median had shorter islet graft survival (triglycerides: 39.7 +/- 6.1 vs. 61.3 +/- 6.6 months, P = 0.029, and VLDL: 41.5 +/- 5.7 vs. 62.8 +/- 7.3 months, P = 0.032). Total, LDL, and HDL cholesterol did not influence islet function. Triglycerides (odds ratio 2.97 [95% CI 1.03-8.52], P = 0.044) maintained its association with graft failure after adjustments for confounders. CONCLUSIONS Higher baseline triglycerides are associated with earlier decline in islet graft function. Prospective clinical trials should address whether it is directly caused by lipotoxicity and if strategies focusing on lowering serum lipids may prolong islet graft survival.

The aim of this study was to evaluate the importance of nonalbumin-predominant proteinuria on kidney function (KF) after islet transplantation (ITx). Twenty-four-hour proteinuria and albuminuria were available in 27 recipients. KF was assessed by serum creatinine and estimated glomerular filtration rate (eGFR) was calculated by Modification of Diet in Renal Disease formula. Correlations between eGFR and albuminuria (r = -0.422, p < 0.001) were higher than with proteinuria (r = -0.223, p < 0.001; p = 0.006 for comparison between correlations). Nineteen (70%) subjects had proteinuria >or= 300 mg/24 h during the follow-up. Subjects were divided into three groups according to urinary protein excretion patterns: no proteinuria (n = 8), nonalbumin-predominant (n = 8), and albumin-predominant (n = 11) proteinuria. Proteinuria >or= 500 mg/24 h was observed only among patients with albumin-predominant proteinuria (64%; p = 0.002) and these patients had the lowest eGFR means post-ITx (no proteinuria: 84.2 +/- 16.4 vs. nonalbumin: 69.1 +/- 13.8 vs. albumin-predominant proteinuria: 65.5 +/- 16.6 ml/min/1.73 m(2), p = 0.044 for first vs. last group). In conclusion, high frequency of proteinuria was observed after ITx. However, it seems to be milder and have less impact on KF when albumin is not the major source of proteinuria. Prospective evaluation of proteinuria, including tubular function markers, should be performed to elucidate the mechanisms of kidney damage in this population.

Background: Body fat accumulation decreases insulin sensitivity. It has being associated with earlier onset of type 1 diabetes mellitus (DM) and islet graft failure. The aim of this study was to evaluate whether insulin resistance, characterized by risk factors for type 2 DM, can predict islet graft survival in type 1 DM islet transplant (ITx) recipients., Methods: Demographic, anthropometrical, and laboratory data, as well as family history of type 2 DM (first degree relatives), were collected from 44 ITx recipients. Risk factors for type 2 DM, such as positive family history of type 2 DM (n=11) and overweight (body mass index >25 kg/m2; n=14), were analyzed separately and in combination, which was designated as "type 2 DM phenotype" (n=5). Differences in outcomes (time-to-graft dysfunction and failure) were compared using Kaplan-Meier curves. Cox regression analysis was performed to control for possible confounding factors., Results: Neither positive family history of type 2 DM nor overweight at baseline could predict islet function outcomes after ITx. However, when both risk factors were grouped, the "type 2 DM phenotype" was associated with earlier islet graft failure (mean estimate graft survival 25.7+/-9.1 vs. 54.1+/-5.2 months, P=0.022). These results were sustained after adjustments for confounding variables (OR 5.20, 95% CI 1.12-24.0)., Conclusions: Predisposition for type 2 DM can coexist with the type 1 DM phenotype and is associated with earlier decline in islet graft function. Prospective clinical trials should address whether it is associated with decreased insulin sensitivity and if insulin sensitizers play a role in prolonging islet graft survival.

The initial success of islet transplantation (ITx) is followed by graft dysfunction (GDF) and insulin reintroduction. Exenatide, a GLP-1 agonist, increases insulin and decreases glucagon secretion and has potential for beta-cell regeneration. To improve functional islet mass, exenatide treatment was given to ITx recipients with GDF. The objective of this study was to assess metabolic and hormonal effects of exenatide in GDF. In this prospective, single-arm, nonrandomized study, 11 type 1 diabetes recipients of ITx with GDF had HbA1c, weight, insulin requirements, and 5-h mixed meal tolerance test (MMTT; with/without exenatide given before test) at baseline, 3, 6, and 12 months after initiating exenatide treatment. Baseline MMTT showed postprandial hyperglycemia and hyperglucagonemia. Daily exenatide treatment resulted in improved glucose, increased amylin/insulin ratio, and decreased proinsulin/insulin ratio as assessed by MMTT. Glucagon responses remained unchanged. Exenatide administration 1 h before MMTT showed decreased glucagon and glucose at 0 min and attenuation in their postprandial rise. Time-to-peak glucose was delayed, followed by insulin, proinsulin, amylin, and C-peptide, indicating glucose-driven insulin secretion. Five subjects completed 12-month follow-up. Glucose and glucagon suppression responses after MMTT with exenatide were no longer observed. Retrospective 3-month analysis of these subjects revealed higher and sustained glucagon levels that did not suppress as profoundly with exenatide administration, associated with higher glucose levels and increased C-peptide responses. In conclusion, Exenatide suppresses the abnormal postprandial hyperglucagonemia and hyperglycemia observed in GDF. Changes in amylin and proinsulin secretion may reflect more efficient insulin processing. Different degrees of responsiveness to exenatide were identified. These may help guide the clinical management of ITx recipients.

Many islet transplant recipients have medical conditions that could interfere with the accuracy of HbA1c measurements (e.g., anemia/dapsone use). Fructosamine is less prone to have clinical interferences and reflects glucose control in a shorter period of time than HbA1c. This study aimed to validate fructosamine use in islet transplant subjects and to evaluate its effectiveness as a predictor for islet graft dysfunction. Thirty-three islet transplant recipients who had concomitant fructosamine and HbA1c data available were retrospectively analyzed. HbA1c, fructosamine, mean capillary blood glucose, and islet graft function (fasting C-peptide/glucose ratio) were assessed. There was a significant and positive association between fructosamine and HbA1c (p < 0.0001). Both variables were also positively associated with mean overall and fasting capillary glucose. Neither fructosamine nor HbA1c was shown by ROC analysis to significantly discriminate between periods with and without subsequent graft dysfunction. HbA1c >6% was predictive of this outcome 1 month in advance (OR 2.95, p = 0.003). However, although significantly associated with graft dysfunction, use of this cutoff as a predictor of dysfunction has poor sensitivity (50%) and specificity (77.6%). Fructosamine above the normal range (>270 mumol/L Quest Diagnostics) was also predictive of ensuing dysfunction (OR 2.47, p = 0.03); however, it had similarly poor sensitivity (62%) and specificity (64%). Fructosamine can be used as an alternative to HbA1c for glycemic assessment in islet transplant recipients in situations with HbA1c assay interference. Neither HbA1c nor fructosamine are good predictors of islet graft dysfunction.

Background: Progressive graft dysfunction (GDF) and loss of insulin independence (II) have been invariably observed in islet transplant recipients under the "Edmonton protocol." To reestablish II, we performed supplemental islet infusions (SI) in recipients of allogeneic islet transplant alone, displaying GDF. To improve the engraftment and long-term graft function of SI, exenatide (EXN) and etanercept treatment at islet infusion, and long-term EXN treatment were tested in a non-randomized pilot clinical trial., Methods: Patients with GDF received SI under Edmonton-like immunosuppression with daclizumab induction, either without interventions (SI-control; n=5) or with EXN and etanercept treatment (SI-EXN; n=4). Clinical and metabolic profiles were assessed during 18-month follow-up., Results: Long-term II (18 months) was observed in 100% of SI-EXN and in 20% of SI-control (P=0.04). SI-EXN subjects demonstrated restoration of function better than that seen after initial islet infusions. Comparison of SI-EXN and SI-control groups demonstrated better responses in SI-EXN subjects at 3 months post-SI. During the 18 months of follow-up, function was sustained in the SI-EXN subjects better than in SI-controls. Acute effects of EXN during mixed meal tolerance test and intravenous glucose tolerance test results in improved first and second phase insulin release in response to intravenous glucose tolerance test and suppressed postprandial hyperglucagonemia after mixed meal tolerance test., Conclusion: These results suggest that the combination of EXN and etanercept improve engraftment and long-term islet survival and function in subjects undergoing SI. This data, however, must be interpreted with some caution because of small sample size, lack of randomization, and sequential comparison with historical controls.

Objective: To determine the impact of islet transplantation (ITx) on hypoglycemia awareness in patients with unstable type 1 diabetes and its relation to islet function., Research Design and Methods: A total of 31 ITx recipients were studied. Hypoglycemia unawareness was assessed using the Clarke hypoglycemic score (0 = no hypoglycemia; >or=4 = hypoglycemia unawareness). Subjects were grouped based on graft function: off-insulin (n = 8), graft dysfunction (on-insulin and stimulated C-peptide >or=0.3 ng/ml, n = 13), and graft failure (stimulated C-peptide <0.3 ng/ml, n = 10, evaluated 11.5 +/- 14.5 months after graft failure)., Results: The hypoglycemia score improved after ITx when compared with baseline values (before vs. after: 5.29 +/- 1.51 vs. 1.35 +/- 1.92, P < 0.001). This result was sustained even after patient stratification based on islet function (pre vs. post off-insulin: 5.63 +/- 2.00 vs. no hypoglycemia reported; graft dysfunction: 5.31 +/- 1.49 vs. 1.15 +/- 1.63, P < 0.001; and graft failure: 5.00 +/- 1.16 vs. 2.70 +/- 2.26, P = 0.014)., Conclusions: The improved metabolic control achieved with ITx can restore hypoglycemia awareness in patients with type 1 diabetes, persisting even after islet graft failure.

Allogeneic islet transplantation is becoming a treatment option for patients with unstable type 1 diabetes mellitus (T1DM). Around 80% of the islet recipients achieve insulin independence after one or two islet infusions under "Edmonton-like" immunosuppressive protocol, but only 10% will remain insulin independent over the long term. Islet transplantation leads to glucose stabilization, and severe hypoglycemia is prevented even in patients back on insulin injections. Thus, islet transplantation has achieved the proposed targets in patients with unstable T1DM: normalizing blood glucose and hemoglobin A(1c), preventing severe hypoglycemic episodes, and improving quality of life. The current aims of islet transplantation programs are to maintain the success achieved and to overcome remaining obstacles and limitations.

Background: To investigate whether changes of nutritional status and behavior are associated with islet transplantation (ITx) and to assess their possible mechanisms., Methods: In this observational study, 52 subjects with type 1 diabetes, 30 of whom received ITx, underwent nutritional assessments. The study consisted of questionnaires complemented by a dietary intake recording, anthropometric measurements, and body composition analysis. Laboratory tests were also reviewed as part of the follow up., Results: After ITx, significant reductions in body weight (3.7 kg; P<0.0001), body mass index (1.39 kg/m2; P<0.0001), waist circumference (3.96 cm; P=0.006), and fat weight (3.28 kg; P<0.01) were observed. The average consumption of carbohydrate and protein were also lower than pretransplant, together with some micronutrients (vitamins B12 and B6, zinc, and phosphorus). Insulin administration and changes in A1C were not associated with a significant change in anthropometric measurements. Subjects on exenatide after ITx showed significantly lower weight and body mass index than those not taking exenatide., Conclusions: ITx is associated with modifications in nutritional behavior and status. Drugs and health conditions are likely to be at least in part responsible for these changes, but a voluntary modification of eating habits by the patients also plays a role. Strict monitoring of nutritional parameters, counseling by experts in nutrition, and multivitamin/mineral supplement after ITx could be of benefit to the patients.

The authors report a 36-year old man, who had hepatocellular carcinoma with lung metastasis and presented with coma from hypoglycemia. Serum insulin and c-peptide level were suppressed. Serum cortisol level was appropriately increased during the event. He needed glucose at least 3.65 mg/kg/min intravenously to maintain euglycemia. Cytoreduction of the tumor was not possible due to advanced stage disease. The patient had several episodes of morning hypoglycemia, despite having oral prednisolone 40 mg/day. However, glucose requirement was decreased after steroid usage. Normoglycemia was accomplished by adjunctive frequent high carbohydrate meal. Prednisolone was replaced to a lower dosage dexamethasone (2 mg/day). He did not have recurrent hypoglycemia as long as he had a midnight snack. Articles regarding hypoglycemia in HCC were extensively reviewed.