Quantifying Hepatic Mitochondrial Fluxes in Humans

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05305287
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Pioglitazone — DRUG
    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.
  • Placebo — OTHER
    Placebo for pioglitazone

Study Details

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

Key Dates

Start date
Nov 1, 2022
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • 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

Primary Outcome Measure

Effect of pioglitazone on hepatic mitochondrial TCA cycle fluxes [ Time Frame: Baseline, week 16 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Texas Diabetes Institute - University Health SystemSan AntonioTexas78207
Andrea Hansis-Diarte, MPh
[email protected]
210-567-6691
Luke Norton, PhD
[email protected]
210-567-0739
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-

Find similar trials in San Antonio, TX

By condition
Type 2 diabetes
By specialty
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By research site
Texas Diabetes Institute - University Health System· San Antonio, TXUniversity of Texas Health Science Center at San Antonio· San Antonio, TX

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