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Quantifying Hepatic Mitochondrial Fluxes in Humans

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

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ClinicalTrials.gov IDNCT05305287
PhasePHASE4
Enrollment60
SponsorThe University of Texas Health Science Center at San Antonio
Age18 Years – 80 Years
SexALL
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Conditions studied

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

About this study

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

Interventions

Primary outcomes

Eligibility information

T2D with NAFL Inclusion Criteria: * 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). Exclusion Criteria: * 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 T2D with NASH Inclusion Criteria: * 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 Criteria: * 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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.