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This study observes how Dapagliflozin affects body composition in people with Type 2 Diabetes who are not well-controlled on Metformin at SMS hospital Jaipur.

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. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/03/082592
Enrollment
60
Registered
2025-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Bhavya Raj
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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. 2. Patients giving consent for the study.

Exclusion criteria

Exclusion criteria: 1. Patients whose BMI less than 20 and BMI more than 35 (morbid obese) 2. Patients with any other comorbidities like dyslipidemia, hypertension, cardiac disorders etc. 3. Patients with evidence of micro or macrovascular complications.

Design outcomes

Primary

MeasureTime frame
1. The proportion of patients on dapagliflozin showing reduction in total body fat ,total body lean mass, total body fat percentage using DEXA Scan. 2. The proportion of patients showing changes in VAT and SAT Score using MRI 3. The proportion of patients showing changes in physical parameters like BMI, body weight and waist circumferenceTimepoint: 1. 0 month. 2. 3 months. 3. 6 months.—

Secondary

MeasureTime frame
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.Timepoint: 1. 0 month. 2. 3 months. 3. 6 months.—

Countries

India

Contacts

Public ContactCharu Jain

Sawai Man Singh Medical College

jaincharujaincharu2007@gmail.com9829269332

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026