Status:
RECRUITING
Quantifying Hepatic Mitochondrial Fluxes in Humans
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Non-Alcoholic Fatty Liver Disease
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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
Detailed Description
The study team will examine hepatic mitochondrial TCA flux and pyruvate cycling (oral \[U-13C\]-propionate), hepatic gluconeogenesis (oral 2H2O), and hepatic insulin sensitivity (intravenous \[3,4-13C...
Eligibility Criteria
Inclusion
- T2D with NAFL
- 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
- 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 = 18-80 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).
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05305287
Start Date
November 1 2022
End Date
March 31 2027
Last Update
January 9 2026
Active Locations (2)
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1
Texas Diabetes Institute - University Health System
San Antonio, Texas, United States, 78207
2
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229