The effects of vitamin D supplementation on metabolic factors and obesity indices among omentin gene polymorphism genotypes in women with prediabetes

Phase 3

Recruiting

Conditions: Prediabetes.
Abnormal glucose tolerance test
R73.0

Registration Number: IRCT20100408003664N26

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 48

Inclusion Criteria

Willingness to cooperate
Women aged 18 to 65 years with prediabetes
Body mass index in the range of 30-40 Kg/m2

Exclusion Criteria

Serum Vitamin D Levels higher than 100 µg / L
Smoking and alcohol
Pregnancy and lactation
Intake of various drugs, including drugs affecting blood sugar and lipid levels
Intake of drugs or dietary supplements affecting the body weight
Surgery in last three months
Having chronic neurological diseases, diabetes, cardiovascular, liver, kidney, Cushing's syndrome, rheumatoid arthritis, cancer and other diseases

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic indices. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Glycemic indexes (from indicators of metabolic status) including fasting blood sugar by enzymatic method, insulin by ELISA and insulin resistance by formula, will be measured or calculated.;Lipid profile. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Lipid profile ( from indicators of metabolic status) including total cholesterol, triglycerides and high-density lipoprotein will be measured enzymatically, and low-density lipoprotein will be calculated using the friedwald formula.;Omentin. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: ELISA.;Serum Vitamin D. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: ELISA.

Secondary Outcome Measures

Name	Time	Method
Obesity indices. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Obesity indices including weight with scales and waist circumference and hip circumference will be measured with a tape measure. Body mass index will be calculated with the formula.;Body composition. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Body composition will be measured by Bio impedance (BIA) method usingTanita body composition analyzer.;Dietary intake. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: The food record questionnaire will be used to assess food intake including energy, carbohydrate, protein and fat.