| Trial ID: | L0120 |
| Source ID: | NCT00994682
|
| Associated Drug: |
Pioglitazone
|
| Title: |
University of Texas H.S.C. San Antonio Pioglitazone in Non-Alcoholic Steatohepatitis Trial (UTHSCSA NASH Trial)
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT00994682/results
|
| Conditions: |
Nonalcoholic Steatohepatitis|Nonalcoholic Fatty Liver Disease|Type 2 Diabetes Mellitus
|
| Interventions: |
Drug: Pioglitazone study drug|Drug: Placebo|Drug: Pioglitazone Open Label
|
| Outcome Measures: |
Liver Histology (Using Kleiner et al Criteria, Hepatology 2005)|Number of Participants With Resolution of NASH|Mean Individual Histological Scores|Individual Histological Scores|Liver Transaminases (AST and ALT).|Liver Fat by Magnetic Resonance and Spectroscopy (MRS).|Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Hepatic Insulin Sensitivity|Adipose Tissue Insulin Sensitivity|Skeletal Muscle Insulin Sensitivity|Body Mass Index (BMI)|Total Body Fat|Plasma Biomarkers Relevant to Hepatic Inflammation, Apoptosis and Fibrosis (Adiponectin).|Plasma Biomarkers Relevant to Hepatic Inflammation, Apoptosis and Fibrosis (CK-18).|Prevention of the Onset of T2DM and/or Reversal From IFG/IGT to NGT in Non-diabetics.|Osteoporotic Fractures|Molecular Pathways of Liver Glucose and Lipid Signaling; Inflammatory Pathways; Oxidative Stress; Other.|Bone Mineral Density
|
| Sponsor/Collaborators: |
University of Florida|The University of Texas at San Antonio
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 4
|
| Enrollment: |
176
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
December 2008
|
| Completion Date: |
December 2014
|
| Results First Posted: |
April 5, 2017
|
| Last Update Posted: |
April 5, 2017
|
| Locations: |
Bartter Research Unit, Audie L Murphy VA Hospital, San Antonio, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT00994682
|
