Quantitation of Hepatic Mitochondrial Fluxes in Humans With Nonalcoholic Fatty Liver Disease (NAFLD)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

• 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).

Locations
United States
Texas
Texas Diabetes Institute - University Health System
RECRUITING
San Antonio
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Contact Information
Primary
Luke Norton, PhD
nortonl@uthscsa.edu
210-567-0739
Backup
Andrea Hansis-Diarte, MPH
hansisdiarte@uthscs.edu
210-567-3208
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 60
Treatments
Experimental: NAFL TZD
T2D with non-alcoholic fatty liver (NAFL), treated with pioglitazone
Placebo_comparator: NAFL Placebo
T2D with non-alcoholic fatty liver (NAFL), treated with placebo
Experimental: NASH TZD
T2D with non-alcoholic steatohepatitis (NASH), treated with pioglitazone
Placebo_comparator: NASH Placebo
T2D with non-alcoholic steatohepatitis (NASH), treated with placebo
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov

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