Obesity Clinical Trial
Official title:
Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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