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Quantifying Hepatic Mitochondrial Fluxes in Humans

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Liver biopsies will be obtained before and after treatment for the diagnosis of NAFL/NASH and for molecular analyses."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study measures how the liver’s tiny energy-making parts work before and after 16 weeks of pioglitazone, a drug that helps the body use insulin. It is for adults with type 2 diabetes and either nonalcoholic fatty liver (NAFL) or fatty liver with inflammation (NASH).

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–80, with a body mass index (BMI) of 25–40, a measure of weight compared with height.
  • Type 2 diabetes confirmed by a sugar drink test: blood sugar of at least 200 mg/dL after 2 hours.
  • Diabetes treated with diet, metformin, and/or a sulfonylurea medicine, and good general health based on an exam, health history, and blood tests.
  • HbA1c of 7–10%. This blood test measures average blood sugar.
  • Weight has stayed within 4 pounds over the past 3 months.
  • No medicines that affect blood sugar other than diabetes medicines.
  • Moderate or severe liver fat: FibroScan grade S2/S3, matching at least 10% liver fat on an MRI scan.
  • For the NAFL group: no or little liver scarring (FibroScan F0/F1). For the NASH group: moderate or severe liver scarring (F2/F3).

Who can't join

  • Drinking more than 14 units of alcohol a week for women or 21 units for men.
  • Cirrhosis, which is stage 4 liver scarring.
  • Other long-term liver disease, including alcohol-related disease, hepatitis B or C, primary biliary cholangitis (bile duct disease), or suspected or confirmed liver cancer.
  • Type 1 diabetes or a positive GAD antibody test, which can be a sign of immune-related diabetes.
  • Prior drug treatment or more than 3 months of metformin use is listed as a reason for exclusion. This conflicts with the allowed diabetes treatments above; ask the study team to clarify.
  • Proliferative retinopathy, an eye disease with abnormal blood vessel growth.
  • More than 300 mg of albumin, a protein, in the urine per day.
  • A history of class III or IV heart failure, the more severe levels of heart failure.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

TX