Hypovitaminosis D, Obesity, Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, vitamin D, cholecalciferol, obesity
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3(cholecalciferol)
Sponsors
Rashid Centre for Diabetes and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glycemic control | 6 months | HbA1c, Fasting Blood glucose, C-peptide |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Profile | 6 months | Serum Total cholesterol, LDL-C, HDL-C, Triglyceride, Apolipoprotein A and B |
| Vitamin D | 6 months | Serum 25-hydroxyvitamin D, Parathyroid hormone, Calcium, Phosphate, Alkaline phosphatase |
| Other metabolic markers | 6 months | High sensitive C-Reactive Protein, Creatinine, Thyroid stimulating hormone, Systolic Blood pressure, Diastolic Blood pressure |
| Obesity Parameter | 6 monhts | Weight, BMI, waist circumference, Fat mass, Muscle mass, water mass |
Countries
United Arab Emirates
Outcome results
None listed