RecruitingPhase 2NCT04501406

Low-Dose Pioglitazone in Patients With NASH (AIM 2)

Effect of Low-Dose Pioglitazone in Patients With Nonalcoholic Steatohepatitis (NASH)

Sponsor

University of Florida

Enrollment

166 participants

Start Date

Dec 15, 2020

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Mellitus (T2DM)Nonalcoholic Steatohepatitis

Summary

To determine the safety and efficacy of low-dose pioglitazone (15 mg per day) on liver histology in in patients with T2DM with biopsy-proven nonalcoholic steatohepatitis (NASH).

Eligibility

Min Age: 21 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a low dose of pioglitazone (a diabetes medication) can help treat NASH — a type of serious liver disease caused by fat buildup and inflammation — in people who also have type 2 diabetes. **You may be eligible if...** - You are between 21 and 75 years old - You have been diagnosed with type 2 diabetes - You have NASH (non-alcoholic steatohepatitis), confirmed by a liver biopsy or imaging - You are not already taking pioglitazone or similar medications **You may NOT be eligible if...** - You have significant liver disease from other causes (such as alcohol, hepatitis B or C, or autoimmune liver disease) - You have heart failure or a history of bladder cancer - You have severe kidney problems - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPioglitazone

An insulin-sensitizer FDA-approved to treat hyperglycemia caused by type 2 diabetes.

OTHERPlacebo

Placebo looks just like pioglitazone and is given in the same way but has no active drug in it.

Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT04501406

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