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Quantifying Hepatic Mitochondrial Fluxes in Humans

ConditionsNon-Alcoholic Fatty Liver DiseaseType 2 DiabetesMitochondrial Metabolism Disorders
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Placebo for pioglitazone

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: NAFL TZDExperimental treatment 1 intervention
Group B: NAFL PlaceboPlacebo comparator 1 intervention
Group C: NASH TZDExperimental treatment 1 intervention
Group D: NASH PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Effect of pioglitazone on hepatic mitochondrial TCA cycle fluxes

Quantitated using a combine stable isotope approach before and after treatment with pioglitazone

Time frame
Baseline, week 16

Secondary outcomes

1

Mean absolute change from baseline in liver fat content by magnetic resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

Mean absolute change from baseline in liver fat content by MRI-PDFF

Time frame
Baseline, Week 16
2

Mean change from baseline in body weight

Mean change from baseline in body weight

Time frame
Baseline, Week 16
3

Mean change from baseline in body composition

Mean change from baseline in lean and fat mass measured by DEXA

Time frame
Baseline, Week 16
4

Quantitate the effect of pioglitazone on liver histology by improvement of fibrosis

Percentage of Participants with ≥1 Point Decrease in Fibrosis Stage with No Worsening of NASH on Liver Histology

Time frame
Week 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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