A Open-label Randomized controlled trial to compare the efficacy of Dapagliflozin and Teneligliptin on liver fat reduction and on Metabolic Parameters in type 2 Diabetes patients with MAFLD"
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Dr Jaideep CK
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change in the liver fat content measured by USG.
Overview
Brief Summary
This Open-label, randomized controlled trial will compare the efficacy of dapagliflozin and teneligliptin on liver fat reduction and metabolic parameters in patients with Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). MAFLD is a prevalent liver condition strongly associated with metabolic disorders such as diabetes, obesity, and hypertension. While both dapagliflozin (SGLT2 inhibitor) and teneligliptin (DPP-4 inhibitor) are used for diabetes, emerging evidence suggests they may have additional benefits on liver health. This study aims to evaluate and compare the impact of these drugs on liver fat content, blood sugar levels, body mass index, liver enzymes, and blood pressure over three months. The findings could guide better treatment strategies for MAFLD in the Indian population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults Patients aged 20–65 years diagnosed with MAFLD giving written informed consent .
- •T2DM patient with MAFLD eligible for treatment with Dapagliflozin or Teneligliptin .
- •Diagnosed with MAFLD based on imaging evidence of hepatic steatosis and metabolic dysfunction.
Exclusion Criteria
- •Type 1 diabetic mellitus History of other chronic liver disease Eg Viral hepatitis autoimmune hepatitis alcohol related liver disease.
- •History of chronic kideny disease, eGFR less than 30 ml per min per 1.73m
- •History of alcohol intake more than 30 mg/day in men,more than 20mg/day in women.
- •Pregnancy or lactation History of ischemic heart disease.
- •Cognitively impaired.
Outcomes
Primary Outcomes
Change in the liver fat content measured by USG.
Time Frame: 12 week
Secondary Outcomes
- Changes in glycemic parameter.LFT,Lipid profile,BP,BMI.(12 week)
Investigators
Jaideep CK
AIIMS BIBINAGAR