| Outcome Measures: |
Primary: Effect of pioglitazone on hepatic mitochondrial TCA cycle fluxes, Quantitated using a combine stable isotope approach before and after treatment with pioglitazone, Baseline, week 16 | Secondary: 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, Baseline, Week 16|Mean change from baseline in body weight, Mean change from baseline in body weight, Baseline, Week 16|Mean change from baseline in body composition, Mean change from baseline in lean and fat mass measured by DEXA, Baseline, Week 16|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, Week 16|Quantitate the effect of pioglitazone on NAFLD Activity Score (NAS), Percentage of Participants that Achieve a ≥2 Point Decrease in NAS on Liver Histology, with ≥1 Point Reduction in at Least 2 NAS Components, Week 16|Examine the effect of pioglitazone on non-invasive markers of NAFLD, Mean change from baseline in Fibrosis-4 (FIB-4), transient elastography (Fibroscan®), NAFLD fibrosis score (NFS), alanine transaminase (ALT) and aspartate transaminase (AST), Baseline, Week 16|Effect of pioglitazone on the hepatic lipidome, Lipidomics will be carried out using mass-spectrometry methods, Baseline, Week 16|Effect of pioglitazone on hepatic gene regulatory networks, Multimodal RNA-Seq and ATAC-Seq will be used to examine gene regulatory networks in liver samples, Baseline, Week 16
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| Locations: |
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
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