Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Time Restricted Intermittent Fasting: No calorie restriction but divided into only two meals a day (morning and evening) and fasting for rest of the time.
The intervention will be follo
Sponsors
Aditi Rajesh Deshmane
Eligibility
Inclusion criteria
Inclusion criteria: HbA1c upto 8% Duration of diabetes less than 5 years Having only Metformin or Drug Naive BMI between 25 to 34.9 No history of weight loss of more than 5kg in last 3 months
Exclusion criteria
Exclusion criteria: Individuals with TIDM Individuals with T2DM more than 5 yrs Individuals treated with anti diabetic medicine like â?? Sulphonylureas, Meglitinides, AlphaGlucosidase Inhibitor (AGIs), GLP 1 Agonist Individuals treated with Insulin • Pregnant women or Lactating Women or Women with Gestational Diabetes • People with any diabetes complications like Diabetic retinopathy, Diabetic Kidney Disease(Chronic or Acute), Pancreatitis and Liver failure • History of having unstable angina or myocardial infarction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic Variability measured with Time in Range Metric using a Continuous Glucose Monitoring System (CGM) for 14 days (Freestyle libre Pro By Abbott)Timepoint: Baseline, At end of 1st Intervention (3 months/12 weeks) and At the end of 2nd Intervention ( 6 months/24 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adherence to the prescribed diet at 3 and 6 monthsTimepoint: At end of 1st Intervention (12 weeks/3 months)and At the end of 2nd Interventions (24 weeks/6 months);Cardio metabolic Parameters like â?? Weight, BMI, Fasting Blood Glucose, Postprandial Blood Glucose, HbA1c, fasting Lipid Profile, Postprandial TG and CRP , Time Period â?? 0,3,and 6 months Timepoint: Baseline (0 weeks), End of 1st Intervention (12 weeks), End of 2nd Intervention (24 weeks) ;Diet related Quality of life and Health Related Quality of life at 3 and 6 monthsTimepoint: At end of 1st Intervention (12 weeks/3 months)and At the end of 2nd Interventions (24 weeks/6 months) | — |
Countries
India
Contacts
Public ContactDr Arti S Muley
Symbiosis International (Deemed University)
Outcome results
None listed