Retrospective analysis to see the effect of Freedom from diabetes protocol on management of prediabetes/type 2 diabetes/obesity in India
Not Applicable
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2024/03/064596
- Lead Sponsor
- Freedom from diabetes research foundation (Host Institution)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age between 18 to 75 years
2. Confirmed diagnosis of prediabetes or type 2 diabetes and/or BMI more than 23 kg/m2
Exclusion Criteria
1. Diabetes type other than type 2 like LADA, MODY, gestational
2. Those with complete data
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.At least 10% reduction in weight at one year & HbA1c less than 6.5% or 48 mmol/mol without the use of pharmacotherapy at 1 year. <br/ ><br>2. BMI below 23 or least 3 point drop <br/ ><br>3. Reduction in mental health scores to below 10 <br/ ><br>4. At least 10% improvement in lipid levels <br/ ><br>Timepoint: Weight, HbA1c and lipid profile at Baseline, 6 month, 1 year <br/ ><br>Mental health questionnaire at baseline and at 6 months
- Secondary Outcome Measures
Name Time Method Improvement in other biochemical parameters like serum creatinine, eGFR, SGPT, SGOT, urine microalbumiuria, C-reactive protein.Timepoint: Biochemical parameters will be assessed at baseline, 6 months and at 1 year