The effects of vitamin D supplementation on glycemic control and oxidative stress parameters in patients with type 2 diabetes mellitus
Not Applicable
Completed
- Conditions
- Type 2 diabetes mellitusNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN25609316
- Lead Sponsor
- Primary Health Care Center Podgorica
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34489860/ (added 17/01/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
1. Diabetes mellitus type 2
2. = 30 years of age
3. Good metabolic control (HbA1c = 7 %)
4. Treated with metformin and lifestyle advice
Exclusion Criteria
1. Use of vitamin D supplements and any diabetes pharmacotherapy other than metformin
2. Use of drugs which affect the metabolism of vitamin D (corticosteroids and anticonvulsants)
3. Severe anemia
4. Chronic liver or kidney failure
5. Alcoholism
6. Pregnancy
7. Malabsorption
8. Urolithiasis
9. Hypercalcemia
10. Body mass index (BMI) = 40 kg/m2
11. Presence of acute or chronic inflammatory conditions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Glycemic control measured through assessing blood levels of glycated hemoglobin (HbA1c) immunoturbidimetrically at baseline, 3 months and 6 months.<br> 2. Insulin resistance measured using levels of HOMA-IR (the homeostasis model assessment of insulin resistance calculated by the formula: HOMA-IR=Fasting Blood Glucose (mmol/L)×Fasting Insulin (µIU/L)/22.5) at baseline, 3 months and 6 months<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Atherogenic risk index is determined through the total cholesterol/HDL cholesterol ratio (Castelli risk I) at baseline, 3 months and 6 months<br> 2. Oxidative stress is measured in plasma through markers of:<br> 2.1. Lipid peroxidation measured in plasma and expressed as the Thiobarbituric acid-reactive substances (TBARS) biomarker malondyadehide (MDA) at baseline, 3 months and 6 months<br> 2.2. Advanced oxidation protein product level (AOPP) measured in plasma spectrophotometrically, expressed as chloramine-T equivalents at baseline, 3 months and 6 months<br>