comparison of effectiveness of obeticholic acid and pioglitazone on Non-Alcoholic fatty liver disease in type 2 diabetic patients
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2022/01/039681
- Lead Sponsor
- SRMIST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
ï?· Patients of both male and female aged above 18 years
ï?· Type 2 diabetes mellitus patients diagnosed with NAFLD by imaging modalities such as ultrasonography or CT scan.
1. Presence of cirrhosis
2. Patients with history of alcohol consumption 3 units of alcohol.
3. People who take drugs that can cause fatty liver (amiodarone,
methotrexate, tamoxifen, valproate)
4. Patient with other liver disease .
5. Patients with acute cardiovascular disease within 12 weeks (patients with
unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass grafting, or coronary intervention)
6. People with renal failure, chronic renal disease (estimated glomerular filtration rate <45 mL / min / 1.73 sq.m) or those who are difficult to use the medication due to dialysis
7. Patients with a history of substance abuse or alcohol intoxication within 12 weeks
8. Pregnant and Lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess and compare the effect of obeticholic acid and pioglitazone on liver function and fibroscan score in NAFLD patients. <br/ ><br>2. To assess the ADRs during the study period.Timepoint: 1. To assess and compare the effect of obeticholic acid and pioglitazone on liver function and fibroscan score in NAFLD patients. <br/ ><br>2. To assess the ADRs during the study period.
- Secondary Outcome Measures
Name Time Method To assess & compare the following between obeticholic acid and pioglitazone on Non- alcoholic Fatty Liver Disease in Type 2 Diabetic Patients. <br/ ><br>ï?· The changes in NAFLD Fibrosis score. <br/ ><br>ï?· The changes in NAFLD Fat score. <br/ ><br>ï?· The changes in TyG Index <br/ ><br>ï?· The changes in Hepatic steatosis Index. <br/ ><br>ï?· The changes in degree of Fibrosis measured by Fibro scan. <br/ ><br>ï?· The changes in glucose metabolism (HbA1c, FBS, RBS, PPBS, HOMA- <br/ ><br>IR) <br/ ><br>ï?· The changes in Lipid profile (LDL-C, TG, HDL, TC)Timepoint: 12 weeks