Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- glycemic control
研究概览
简要总结
The incidence of type 2 diabetes mellitus and obesity is increasing at an alarming rate both nationally and worldwide. Accumulating evidence suggests that serum cholecalciferol levels may be inversely related to the prevalence of diabetes, insulin resistance and metabolic syndrome. However, to demonstrate a causal relation between vitamin D and glucose metabolism, evidence from randomized and adequately powered placebo-controlled intervention trials is needed.The trials available on the effect of Vitamin D supplementation are not conclusive. Hence, the purpose of this study was to conduct a double-blind randomized trial in Vitamin D deficient obese type 2 diabetic Emirati population to clarify the effect of vitamin D supplementation on glycemic control and obesity parameters.
详细描述
Vitamin D insufficiency has been reported as a risk factor for the development of type 1 and type 2 diabetes mellitus. In contrast to the findings of the observational studies, the supplementation trials in type 2 diabetes mellitus (T2DM) do not report any definitive conclusions, but it does suggest that supplementation at an early stage in the development of diabetes may be of benefit in delaying progression to clinical T2DM by increasing the pancreatic insulin release and improved insulin resistance plus impaired glucose tolerance.There is also speculation on role of vitamin D in physiology of weight loss and body composition.However, there have been multiple inconsistencies within the reported trial i.e. sample size, dose of vitamin D, frequency of supplementation, and population studied.
Hence the randomised clinical trial was undertaken to study the effect of vitamin D (Cholecalciferol) supplementation on metabolic markers and obesity parameters in the vitamin D deficient obese type 2 diabetic subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •United Arab Emirates national
- •Male or Female
- •Age 30-65 years
- •Diagnosed as type 2 diabetes
- •Body Mass Index ≥30 kg/m2
- •Serum 25 hydroxy Vitamin D ≤ 50nmol/L
排除标准
- •Type 1 diabetes mellitus
- •History or evidence of liver failure (elevated liver function tests) or renal failure ( elevated creatinine)
- •History of malabsorption syndrome.
- •On vitamin D Supplementation
- •On hormone replacement therapy
- •On corticosteroids, anticonvulsants, AIDS medication
结局指标
主要结局
glycemic control
时间窗: 6 months
HbA1c, Fasting Blood glucose, C-peptide
次要结局
- Lipid Profile(6 months)
- Vitamin D(6 months)
- Other metabolic markers(6 months)
- Obesity Parameter(6 monhts)
研究者
Dr.Amena Sadiya
Senior Nutritionist
Rashid Centre for Diabetes and Research