Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)

Conditions
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Type 2 Diabetes Mellitus, Obesity, Hypovitaminosis D

Intervention / Treatment
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* Dietary Supplement: Vitamin D3(cholecalciferol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 group<br>supplemented with 6000IU cholecalciferol/day for 3 months, followed by 3000 IU cholecalciferol/day for next 3 months | Dietary Supplement: Vitamin D3(cholecalciferol)<br> <br> * Other names: cholecalciferol;|
| Placebo Comparator: Placebo group<br>Placebo (starch) capsules identical to vitamin D capsules in appearance | Dietary Supplement: Vitamin D3(cholecalciferol)<br> <br> * Other names: cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control | HbA1c, Fasting Blood glucose, C-peptide | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Profile | Serum Total cholesterol, LDL-C, HDL-C, Triglyceride, Apolipoprotein A and B | 6 months | 
| Vitamin D | Serum 25-hydroxyvitamin D, Parathyroid hormone, Calcium, Phosphate, Alkaline phosphatase | 6 months | 
| Other metabolic markers | High sensitive C-Reactive Protein, Creatinine, Thyroid stimulating hormone, Systolic Blood pressure, Diastolic Blood pressure | 6 months | 
| Obesity Parameter | Weight, BMI, waist circumference, Fat mass, Muscle mass, water mass | 6 monhts | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, vitamin D, cholecalciferol, obesity