Quantifying Hepatic Mitochondrial Fluxes in Humans
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pioglitazone
- Placebo
Treatment groups
60 Participants
are divided into 4 treatment groupsSponsors and collaborators
The University of Texas Health Science Center at San Antonio
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov