Measuring liver metabolism in patients with diabetes and fatty liver

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to quantify hepatic mitochondrial fluxes in patients with type 2 diabetes who have non-alcoholic fatty liver disease (NAFL) and non-alcoholic steatohepatitis (NASH). Participants will undergo a 16-week treatment with the insulin sensitizer pioglitazone, with assessments of liver metabolism conducted before and after the treatment. The study will utilize advanced techniques such as oral and intravenous isotopic tracers to evaluate mitochondrial function and insulin sensitivity, alongside liver biopsies for diagnostic purposes.

Why it matters

Who can join: the full rules

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

Where it's running

• Texas Diabetes Institute - University Health System
  San Antonio, Texas, United States Recruiting
• University of Texas Health Science Center at San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Luke Norton, PhD — The University of Texas Health Science Center at San Antonio
• Study coordinator: Luke Norton, PhD
• Email: nortonl@uthscsa.edu
• Phone: 210-567-0739

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.