RECRUITING

Quantifying Hepatic Mitochondrial Fluxes in Humans

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Conditions

Non-Alcoholic Fatty Liver DiseaseType 2 DiabetesMitochondrial Metabolism DisordersNAFLDDietExercise

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2022-11-01
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05305287

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed T2D based on OGTT (2 h glucose ≥200 mg/dl).
  2. * Treated with diet, metformin, and/or sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;
  3. * age = 18-80 years;
  4. * BMI = 25-40 kg/m2;
  5. * HbA1c = 7-10%; stable body weight (±4 pounds) over the preceding 3-months;
  6. * not taking any medication known to affect glucose metabolism other than antidiabetic medications.
  7. * 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).
  1. * Alcohol consumption \>14 units/week for women and \>21 units/week for men.
  2. * Cirrhosis (fibrosis stage 4).
  3. * Type 1 diabetes and/or GAD positive subjects.
  4. * Subjects not drug naive or have been on metformin more than 3 months.
  5. * Presence of proliferative retinopathy.
  6. * Urine albumin excretion \> 300 mg/day.
  7. * 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.
  8. * History of NY Class III-IV heart failure

Contacts and Locations

Study Contact

Luke Norton, PhD
CONTACT
210-567-0739
nortonl@uthscsa.edu
Andrea Hansis-Diarte, MPH
CONTACT
210-567-3208
hansisdiarte@uthscs.edu

Principal Investigator

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

Study Locations (Sites)

Texas Diabetes Institute - University Health System
San Antonio, Texas, 78207
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • NAFLD
  • Diet
  • Exercise

Additional Relevant MeSH Terms

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