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临床试验/CTRI/2025/08/093475
CTRI/2025/08/093475尚未招募3 期

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"

Dr Jaideep CK1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月11日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Change in the liver fat content measured by USG.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in the liver fat content measured by USG.

时间窗: 12 week

次要结局

  • Changes in glycemic parameter.LFT,Lipid profile,BP,BMI.(12 week)

研究者

发起方
Dr Jaideep CK
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jaideep CK

AIIMS BIBINAGAR

研究点 (1)

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