Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN.
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ABSTRACT: Introduction
To analyse the safety and effectiveness of gliclazide modified release (MR) in adults with type 2 diabetes mellitus participating in Ramadan from three geographically and culturally different regions of the world included in the DIA-RAMADAN study.Methods
DIA-RAMADAN was a real-world, observational, international, non-comparative study. The global study population was divided into three regional subgroups, with data gathered at inclusion 6-8 weeks prior to Ramadan (V0), during Ramadan (4.5 weeks) and 4-6 weeks after Ramadan (V1). Primary endpoint was the proportion of patients reporting ≥ 1 symptomatic hypoglycaemic events (HE), which were collected using a patient diary along with other adverse events.Results
Patient numbers from the three regions were n = 564 (46.5%; Indian sub-continent), n = 354 (29.1%; Middle East) and n = 296 (24.4%; South-East Asia). Patient baseline characteristics, demographics, fasting habits and antidiabetic treatments varied between regions. There were similar proportions of symptomatic HE between regions, with no severe HE. Significant weight reductions were observed in all regions following Ramadan, along with reductions in HbA1c and fasting plasma glucose.Conclusion
These real-world study data indicate that gliclazide MR is safe and effective for management of type 2 diabetes during Ramadan in all three regions studied as part of DIA-RAMADAN.Trial registration
Clinicaltrials.gov identifier NCT04132934. INFOGRAPHIC.
SUBMITTER: Hassanein M
PROVIDER: S-EPMC8179867 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Aim: Many Muslims with Type II diabetes (T2DM) fast during Ramadan, which can put them at increased risk of hypoglycemia. This sub-analysis of the global DIA-RAMADAN study assessed the effectiveness and safety of gliclazide modified release (MR) 60 mg in the Bangladeshi cohort. Materials & methods: DIA-RAMADAN was an international, prospective, observational study conducted in adult T2DM patients intending to fast and receiving gliclazide MR 60 mg once daily for ≥90 days before Ramadan. Dosing was switched from morning to evening at the start of Ramadan. The primary outcome was the proportion of patients with ≥1 symptomatic hypoglycemic event. Secondary outcomes included changes between inclusion (V0) and end of study visit (V1) in glycated hemoglobin (HbA1c), body weight and fasting plasma glucose (FPG). Results: Among the 98 Bangladeshi patients, 80 (81.6%) were at moderate/low-risk (category 3) for fasting and 18 (18.4%) were high-risk (category 2), as per International Diabetes Federation and Diabetes and Ramadan International Alliance (IDF-DAR) guidelines. Gliclazide MR was being prescribed as monotherapy to 59 (60.2%) patients and in combination with metformin to 39 (39.8%). There was no incidence of severe hypoglycemic events. Mean (±SD) HbA1c change from V0 was -0.1 ± 0.8% (p = 0.159). Mean (±SD) changes in FPG and body weight were -0.8 ± 39.7 mg/dl (p = 0.876) and -0.0 ± 1.5 kg (p = 0.810), respectively. Conclusion: In a real-world setting, this sub-analysis in Bangladeshi patients shows that patients with T2DM treated with gliclazide MR 60 mg can fast safely during Ramadan with a very low risk of hypoglycemia, while maintaining glycemic control and body weight.
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Project description:As of April 24, 2020, more than 1. 6 billion Muslims observe the holy fasting month of Ramadan worldwide. The safety of fasting of healthy adult Muslims during the COVID-19 era is debatable. In this perspective, we discuss the available scientific evidence of the advantages of fasting against COVID-19.
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Project description:BackgroundIntermittent fasting is a popular dietary intervention with perceived relatively easy compliance and is linked to various health benefits, including weight loss and improvement in blood glucose concentrations. The mechanistic explanations underlying the beneficial effects of intermittent fasting remain largely obscure but may involve alterations in the gut microbiota.ObjectivesWe sought to establish the effects of 1 mo of intermittent fasting on the gut microbiome.MethodsWe took advantage of intermittent fasting being voluntarily observed during the Islamic faith-associated Ramadan and sampled feces and blood, as well as collected longitudinal physiologic data in 2 cohorts, sampled in 2 different years. The fecal microbiome was determined by 16S sequencing. Results were contrasted to age- and body weight-matched controls and correlated to physiologic parameters (e.g., body mass and calorie intake).ResultsWe observed that Ramadan-associated intermittent fasting increased microbiome diversity and was specifically associated with upregulation of the Clostridiales order-derived Lachnospiraceae [no fasting 24.6 ± 13.67 compared with fasting 39.7 ± 15.9 in relative abundance (%); linear discriminant analysis = 4.9, P < 0.001 by linear discriminant analysis coupled with effect size measurements] and Ruminococcaceae [no fasting 13.4 ± 6.9 compared with fasting 23.2 ± 12.9 in relative abundance (%); linear discriminant analysis = 4.7, P < 0.001 by linear discriminant analysis coupled with effect size measurements] bacterial families. Microbiome composition returned to baseline upon cessation of intermittent feeding. Furthermore, changes in Lachnospiraceae concentrations mirrored intermittent fasting-provoked changes in physiologic parameters.ConclusionsIntermittent fasting provokes substantial remodeling of the gut microbiome. The intermittent fasting-provoked upregulation of butyric acid-producing Lachnospiraceae provides an obvious possible mechanistic explanation for health effects associated with intermittent fasting.
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Project description:ObjectivesIn the current study, we aimed at evaluating the effect of a culturally-based pre-Ramadan education program (PREP) on glycemic control, weight, adherence to post-sunset physical activity, perception of hypoglycemia, and anti-diabetic medication dose adjustment during Ramadan fasting in type 2 diabetics.Study designA total of 1008 type 2 Diabetes patients were offered a culturally-based PREP in addition to the standard of care, two months before Ramadan. A retrospective interview one month after Ramadan compared the fasting experience of PREP attendees (470 patients) with those who merely received standard of care (538 patients) (Non-PREP).ResultsRamadan fasting improved glycemic control with a correlation between HbA1c percent reduction and the number of fasting days (r = -0.290, p = 0.007). More HbA1c and weight percent reduction were observed in PREP attendees compared to the Non-PREP group (-14.8% ± 9.3 vs. -5.4% ± 5.4; p < 0.001; and - 1.96% ± 5.4 vs. -0.39% ± 2.8; p < 0.001, respectively). More commitment to night prayers in the PREP attendees compared to the Non-PREP group, (85.5% prayed >20 nights vs 28.4%; p < 0.001) with more HbA1c and weight percent reduction in the those who performed the prayers more than 20 nights compared to those who performed no prayers (-11.69% ± 8.8 vs -6.28% ± 6.4, p < 0.001; and - 2.76% ±5.1 vs 1.35% ±1.8, p < 0.001, respectively). More perception of true hypoglycemia was associated with PREP attendance (p0.046), insulin treatment (p0.000), and reduction of antidiabetic medication dosage (p0.004). Repeated lowering of antidiabetic medications doses with sequential downsizing of meals' portions, and appetite was reported.ConclusionRamadan fasting was beneficial for people with type 2 diabetes with reduction of HbA1c in correlation with the number of fasting days. Contrasting PREP with Non-PREP participants discovered better HbA1c and weight reduction in the former group even with equal number of fasting days. PREP participants performed more Taraweeh night prayers. The more the prayer nights the more decline of HbA1c and weight was observed. PREP improved perception and response to hypoglycemia with low-dosing of antidiabetic medications, especially insulin.
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