Effect of restriction of calories in diet on cardio-metabolic risk factors among women with prediabetes in a northern district, Kerala
Phase 2
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2022/07/043755
- Lead Sponsor
- Central University of Kerala
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Women aged 30-60 years; 2) overweight or obese (waist circumference >=80 cm);22 3) no prior history of diabetes; 4) not taking any glucose-lowering medications; 5) no prior history of gestational diabetes mellitus (GDM); 6) able to read, write and speak Malayalam, the local language; 7) consents to participate in the trial; 8) diagnosed with i-IFG (fasting plasma glucose [FPG] 5.6-6.9 mmol/l and 2-hr plasma glucose [2-hr PG] <7.8 mmol/l) on a 2-hr oral glucose tolerance test (OGTT).
Exclusion Criteria
Those who does not meet the inclusion criteria is excluded from the studies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of the study is the change in fasting plasma glucose â?¤ 7.0 mmol/l.Timepoint: Blood collection at baseline 1st month and 12 months to measure glycemic FBS
- Secondary Outcome Measures
Name Time Method 1) The Change in HbA1c,Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and body fat composition will be assesed . <br/ ><br>2)The changes in anthropometric measures like weight, BMI, waist circumference and hip circumference will be assesedTimepoint: 1) Glycemic measures will be assesed at baseline and at 12 th month <br/ ><br>2) Anthropometric measures will be measured at baseline , 3rd month, 6thmonth, 9th month and 12 month