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Quantifying Hepatic Mitochondrial Fluxes in Humans

NCT05305287 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-09

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Pioglitazone

An insulin sensitizer and anti-diabetic agent. Participants will be started on 15 mg/day, increased to 30 mg/day at week 2 and then to 45 mg/day at week 4.

OTHER

Placebo

Placebo for pioglitazone

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05305287 on ClinicalTrials.gov