FindTrial
Sign In

comparison of effectiveness of obeticholic acid and pioglitazone on Non-Alcoholic fatty liver disease in type 2 diabetic patients

comparison of effectiveness of obeticholic acid and pioglitazone on Non-Alcoholic fatty liver disease in type 2 diabetic patients- A randomised, controlled, open label, pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039681
Enrollment
70
Registered
2022-01-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Obeticholic acid: Obeticholic acid 5mg OD For 90 days Control Intervention1: Pioglitazone: Pioglitazone 7.5mg OD For 90 days

Sponsors

SRMIST
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 7. Patients with a history of substance abuse or alcohol intoxication within 12 weeks 8. Pregnant and Lactating women

Design outcomes

Primary

MeasureTime frame
1. To assess and compare the effect of obeticholic acid and pioglitazone on liver function and fibroscan score in NAFLD patients. 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. 2. To assess the ADRs during the study period.—

Secondary

MeasureTime frame
To assess & compare the following between obeticholic acid and pioglitazone on Non- alcoholic Fatty Liver Disease in Type 2 Diabetic Patients. ï?· The changes in NAFLD Fibrosis score. ï?· The changes in NAFLD Fat score. ï?· The changes in TyG Index ï?· The changes in Hepatic steatosis Index. ï?· The changes in degree of Fibrosis measured by Fibro scan. ï?· The changes in glucose metabolism (HbA1c, FBS, RBS, PPBS, HOMA- IR) ï?· The changes in Lipid profile (LDL-C, TG, HDL, TC)Timepoint: 12 weeks—

Countries

India

Contacts

Public ContactDr TM Vijayakumar

SRM medical college hospital and research centre

vijaypractice@yahoo.com9003400350

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026