Quantifying Hepatic Mitochondrial Fluxes in Humans

• Status: Recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Pioglitazone

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 = 18-75 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.

• Cirrhosis (fibrosis stage 4).

• 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.

• 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.

• 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 = 18-75 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.

• Cirrhosis (fibrosis stage 4).

• 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.

• 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.

• History of NY Class III-IV heart failure