A prospective observational study on effect of dapagliflozin on body composition In type 2 diabetes mellitus patients inadequately controlled with metformin at SMS hospital, jaipur during 2024-2026.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1. The proportion of patients on dapagliflozin showing reduction in total body fat ,total body lean mass, total body fat percentage using DEXA Scan.
Study Overview
Brief Summary
Adipose tissue contributes to insulin resistance through inflammatory mechanisms, highlighting the importance of managing body composition in type 2 diabetes mellitus (T2DM). Key risk factors for T2DM include obesity, high-caloric diets, and sedentary lifestyles, which have led to a global increase in the disease. While many drugs improve the quality of life for T2DM patients, addressing adiposity is crucial for effective treatment. This study will give us a better understanding about the effect of dapagliflozin on body composition in T2DM patients inadequately controlled on metformin.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All patients of more than 18 years and of either sex whose HbA1C levels are more than 7.5 after at least 3 months of treatment with metformin.
- •Patients giving consent for the study.
Exclusion Criteria
- •Patients whose BMI less than 20 and BMI more than 35 (morbid obese)
- •Patients with any other comorbidities like dyslipidemia, hypertension, cardiac disorders etc.
- •Patients with evidence of micro or macrovascular complications.
Outcomes
Primary Outcomes
1. The proportion of patients on dapagliflozin showing reduction in total body fat ,total body lean mass, total body fat percentage using DEXA Scan.
Time Frame: 1. 0 month. | 2. 3 months. | 3. 6 months.
2. The proportion of patients showing changes in VAT and SAT Score using MRI
Time Frame: 1. 0 month. | 2. 3 months. | 3. 6 months.
3. The proportion of patients showing changes in physical parameters like BMI, body weight and waist circumference
Time Frame: 1. 0 month. | 2. 3 months. | 3. 6 months.
Secondary Outcomes
- 1. The proportion of patients showing improvement in glycemic control using HbA1C and FBG in the study population.(2. The proportion of patients showing improvement on insulin resistance by monitoring adiponectin level.)