Actively Recruiting
Quantifying Hepatic Mitochondrial Fluxes in Humans
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-01-09
60
Participants Needed
2
Research Sites
230 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Quantifying Hepatic Mitochondrial Fluxes in Humans
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed type 2 diabetes based on oral glucose tolerance test (2-hour glucose 20 mg/dl).
- Treated with diet, metformin, and/or sulfonylurea and in good general health based on medical history, physical exam, and routine blood tests.
- Age between 18 and 80 years.
- Body mass index (BMI) between 25 and 40 kg/m2.
- HbA1c between 7% and 10%.
- Stable body weight within 1 pounds over the past 3 months.
- Not taking any medication known to affect glucose metabolism other than antidiabetic medications.
- For NAFL group: evidence of moderate/severe fatty liver (grade S2/S3 on FibroScan corresponding to 210% fat on MRI-PDFF) and no or minimal liver fibrosis (grade F0/F1 on FibroScan).
- For NASH group: evidence of moderate/severe fatty liver (grade S2/S3 on FibroScan corresponding to 210% liver fat on MRI-PDFF) and moderate/severe liver fibrosis (grade F2/F3 on FibroScan).
You will not qualify if you...
- Alcohol consumption greater than 14 units per week for women and greater than 21 units per week for men.
- Cirrhosis (fibrosis stage 4).
- Type 1 diabetes or positive for glutamic acid decarboxylase (GAD) antibodies.
- Not drug naive or have been on metformin for more than 3 months.
- Presence of proliferative retinopathy.
- Urine albumin excretion greater than 300 mg/day.
- Evidence of other chronic liver diseases, including alcoholic liver disease, hepatitis B or C, primary biliary cholangitis, suspected or proven liver cancer, or any liver disease other than NAFLD.
- History of New York Heart Association Class III-IV heart failure.
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Trial Site Locations
Total: 2 locations
1
Texas Diabetes Institute - University Health System
San Antonio, Texas, United States, 78207
Actively Recruiting
2
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
L
Luke Norton, PhD
CONTACT
A
Andrea Hansis-Diarte, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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