Studies liver cell energy changes with pioglitazone in fatty liver and diabetes
Tests pioglitazone against placebo in adults with fatty liver disease and type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Quantifying Hepatic Mitochondrial Fluxes in Humans
Key facts
- Where
- San Antonio, United StatesSee the 2 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 2 diabetes and fatty liver, with or without liver fibrosis. It studies liver energy processes before and after 16 weeks of pioglitazone.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes confirmed by a glucose tolerance test (2 h glucose ≥200 mg/dl (11.1 mmol/L)), with moderate or severe fatty liver (S2/S3 on FibroScan, ≥10% fat on MRI-PDFF). One group has no or minimal liver fibrosis (F0/F1); the other has moderate or severe fibrosis (F2/F3). HbA1c 7-10% (53–86 mmol/mol), BMI 25-40 kg/m2.
- Earlier treatment
- Treated with diet, metformin and/or sulfonylurea. People who have been on metformin for more than 3 months cannot join. No medication known to affect glucose metabolism other than diabetes medicines. Stable body weight (±4 pounds (2 kg)) over the last 3 months.
Main reasons for not taking part
- Alcohol use above 14 units/week for women or 21 units/week for men
- Liver cirrhosis (fibrosis stage 4)
- Other chronic liver disease, such as hepatitis B or C, or liver cancer
- Type 1 diabetes or GAD positive
- Proliferative retinopathy, urine albumin above 300 mg/day, or NY Class III-IV heart failure
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05305287, who can take part
Where in United States
- Texas Diabetes Institute - University Health SystemSan Antonio, United StatesTaking people
- University of Texas Health Science Center at San AntonioSan Antonio, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Texas Health Science Center at San Antonio
- Trial code
- NCT05305287
- Record updated
- 17 August 2026
- Original description
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 pioglitazoneRead full original descriptionShow less
Quantitation of Hepatic Mitochondrial Fluxes in Humans With Nonalcoholic Fatty Liver Disease (NAFLD)
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
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: Subjects not drug naive or have been on metformin more than 3 months; Subjects not drug naive or have been on metformin more than 3 months; 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; History of NY Class III-IV heart failure; T2D with NASH; 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; History of NY Class III-IV heart failure; Urine albumin excretion > 300 mg/day; Urine albumin excretion > 300 mg/day; Alcohol consumption >14 units/week for women and >21 units/week for men; Liver cirrhosis (fibrosis stage 4); Presence of proliferative retinopathy; Alcohol consumption >14 units/week for women and >21 units/week for men; Liver cirrhosis (fibrosis stage 4); Presence of proliferative retinopathy.
T2D with NAFL.