🏛️ Verified NIH Record • Updated 2026-08-12

Quantifying Hepatic Mitochondrial Fluxes in Humans (NCT05305287)

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

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: The University of Texas Health Science Center at San Antonio

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (25 items).

Location: Texas Diabetes Institute - University Health System — San Antonio, Texas

Age range: 18 Years to 80 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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.
  • Subjects not drug naive or have been on metformin more than 3 months.
  • Presence of proliferative retinopathy.
  • Urine albumin excretion \> 300 mg/day.
  • History of NY Class III-IV heart failure T2D with NASH Inclusion 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;

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

  • Texas Diabetes Institute - University Health System — San Antonio, Texas
  • University of Texas Health Science Center at San Antonio — San Antonio, Texas

📞 Contact the Study Coordinator

Phone: (210) 567-0739

Email: nortonl@uthscsa.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗