Quantifying Hepatic Mitochondrial Fluxes in Humans

Description

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

Non-Alcoholic Fatty Liver Disease, Type 2 Diabetes, Mitochondrial Metabolism Disorders

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Study Overview

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Study Details

Study overview

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

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

Quantifying Hepatic Mitochondrial Fluxes in Humans

Condition
Non-Alcoholic Fatty Liver Disease
Intervention / Treatment

-

Contacts and Locations

San Antonio

Texas Diabetes Institute - University Health System, San Antonio, Texas, United States, 78207

San Antonio

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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% fat on MRI-PDFF) and no/minimal hepatic fibrosis (grade F0/F1 on FibroScan).
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center at San Antonio,

Luke Norton, PhD, PRINCIPAL_INVESTIGATOR, University of Texas Health Science Center San Antonio

Study Record Dates

2027-03-31