RecruitingPhase 4NCT05305287

Quantifying Hepatic Mitochondrial Fluxes in Humans

Quantitation of Hepatic Mitochondrial Fluxes in Humans With Nonalcoholic Fatty Liver Disease (NAFLD)


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

60 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

In this study the investigators will quantitate hepatic mitochondrial fluxes in T2D patients with NAFL and NASH before and after 16-weeks treatment with the insulin sensitizer pioglitazone


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study measures how the liver processes energy in people with type 2 diabetes and fatty liver disease (a condition where fat builds up in the liver). Using special metabolic tests, it aims to understand how the liver's energy system (mitochondria) works and how it might be improved. **You may be eligible if...** - You have type 2 diabetes, confirmed by a glucose tolerance test - You are 18–80 years old with a BMI between 25–40 kg/m² - Your HbA1c (blood sugar measure) is between 7–10% and your weight has been stable recently - You have moderate-to-severe fatty liver confirmed by imaging - You are managed with diet, metformin, or sulfonylurea only **You may NOT be eligible if...** - You drink more than 14 units of alcohol per week - You take medications that significantly affect blood sugar beyond the allowed types - You have significant liver scarring (fibrosis) beyond early stages 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 and anti-diabetic agent. Participants will be started on 15 mg/day, increased to 30 mg/day at week 2 and then to 45 mg/day at week 4.

OTHERPlacebo

Placebo for pioglitazone


Locations(2)

Texas Diabetes Institute - University Health System

San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

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NCT05305287


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