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Pioglitazone for Liver and Diabetes Conditions

This study is looking at how a medication called pioglitazone affects the liver in people with Type 2 Diabetes (T2D) and Non-Alcoholic Fatty Liver Disease (NAFLD). Pioglitazone is a drug that helps your body use insulin better. Researchers want to understand how pioglitazone changes the way your liver's cells (mitochondria) create energy. You might be able to join if you are between 18 and 80 years old, have T2D and NAFLD, and meet certain health criteria like a specific HbA1c (a measure of blood sugar over time) range. The study will measure changes in your liver's energy processes after 16 weeks of treatment with pioglitazone to see if it helps.

Study design
This interventional study plans to enroll 60 participants. It compares pioglitazone to a placebo (an inactive substance).
What's involved
You would take pioglitazone or a placebo for 16 weeks, with the pioglitazone dose increasing over the first four weeks. Liver biopsies will be taken before and after treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at baseline and week 16, indicating a follow-up period of at least 16 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05305287

Quantifying Hepatic Mitochondrial Fluxes in Humans

Recruiting
PHASE4Ages 18–80InterventionalBasic science
The University of Texas Health Science Center at San Antonio
~60 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PioglitazonePlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effect of pioglitazone on hepatic mitochondrial TCA cycle fluxes
Measured over Baseline, week 16

Conditions

Non-Alcoholic Fatty Liver Disease
Type 2 Diabetes
Mitochondrial Metabolism Disorders

Explore related trials

Nonalcoholic Fatty Liver DiseaseType 2 Diabetes Mellitus

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Luke Norton, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

Who to contact

Luke Norton, PhD
[email protected]
210-567-0739
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Confirmed T2D based on OGTT (2 h glucose ≥200 mg/dl).
Treated with diet, metformin, and/or sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;
age = 18-80 years;
BMI = 25-40 kg/m2;
HbA1c = 7-10%; stable body weight (±4 pounds) over the preceding 3-months;
not taking any medication known to affect glucose metabolism other than antidiabetic medications.
Evidence of moderate/severe fatty liver (steatosis; grade S2/S3 on FibroScan corresponding to ≥10% fat on MRI-PDFF) and no/minimal hepatic fibrosis (grade F0/F1 on FibroScan).
Confirmed T2D based on OGTT (2 h glucose ≥200 mg/dl).
Treated with diet, metformin, and/or sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;
age = 18-80 years;
BMI = 25-40 kg/m2;
HbA1c = 7-10%;
stable body weight (±4 pounds) over the preceding 3-months;
not taking any medication known to affect glucose metabolism other than antidiabetic medications.
Evidence of moderate/severe fatty liver (steatosis; grade S2/S3 on FibroScan corresponding to ≥10% liver fat on MRI-PDFF) and moderate/severe hepatic fibrosis (grade F2/F3 on FibroScan).

Exclusion

Alcohol consumption \>14 units/week for women and \>21 units/week for men.
Liver cirrhosis (fibrosis stage 4).
Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected/proven liver cancer and any other liver disease other than NAFLD.
Type 1 diabetes and/or GAD positive subjects.
Subjects not drug naive or have been on metformin more than 3 months.
Presence of proliferative retinopathy.
Urine albumin excretion \> 300 mg/day.
History of NY Class III-IV heart failure
Alcohol consumption \>14 units/week for women and \>21 units/week for men.
Liver cirrhosis (fibrosis stage 4).
Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected/proven liver cancer and any other liver disease other than NAFLD.
Type 1 diabetes and/or GAD positive subjects.
Subjects not drug naive or have been on metformin more than 3 months.
Presence of proliferative retinopathy.
Urine albumin excretion \> 300 mg/day.
History of NY Class III-IV heart failure

What this trial measures

  • Effect of pioglitazone on hepatic mitochondrial TCA cycle fluxesBaseline, week 16

    Quantitated using a combined stable isotope approach before and after treatment with pioglitazone