Effect Of Sodium Glucose Co-Transporter-2 (SGLT-2) Inhibitors on Body Mass Index After 3 Months of Use in Diabetic Patients
- Sponsor
- Ariba Shafiq
- Study ID
- NCT07367555
- Phase
- PHASE1
- Status
- Completed
Conditions
- Diabete Mellitus
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Oral 100 gram Empagliflozin tablet along with diet plan and exercise — DRUGoral 100 gram Empagliflozin tablet along with diet plan and exercise
- Diet plan and exercise — OTHEROnly Life style modification was advised. Changes in BMI were assessed.
Study Details
Total of 360 participants were enrolled and prescribed oral 200 mg SGLT-2 tablet. All participants were followed-up for about three months. Body mass index was measured before and after three months and mean change in BMI was assessed.
Key Dates
- Start date
- Oct 1, 2024
- Status verified
- Jan 2026
- Primary completion
- Mar 31, 2025
- Completion
- Mar 31, 2025
Study Design
- Enrollment
- 360 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group A participants with Type II Diabetes MellitusRandomly 180 Individuals with diagnosed type 2 Diabetes Mellitus were allocated group A. These individuals were prescribed oral 100 gram Empagliflozin tablet along with diet plan and exercise. All individuals were followed-up in OPD for 3 months. After 3 months, individuals were assessed again for height, weight, and BMI. Changes in weight and BMI were calculated.
- Active Comparator: Group B participants with Type II Diabetes MellitusRandomly 180 Individuals with diagnosed type 2 Diabetes Mellitus were allocated group A. These individuals were prescribed oral 100 gram Empagliflozin tablet along with diet plan and exercise. All individuals were followed-up in OPD for 3 months. After 3 months, individuals were assessed again for height, weight, and BMI. Changes in weight and BMI were calculated.
Primary Outcome Measure
Weight [ Time Frame: 03 Months ]
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