| Trial ID: | L0964 |
| Source ID: | NCT01002547
|
| Associated Drug: |
Vitamin E
|
| Title: |
NAFLD in T2DM: Prevalence in Hispanics and Role of Treatment
|
| Acronym: |
VA NASH
|
| Status: |
Not recruiting
|
| Study Results: |
Has Results
|
| Results: |
https://clinicaltrials.gov/ct2/show/results/NCT01002547
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: pioglitazone-placebo;Drug: pioglitazone;Dietary Supplement: Vitamin E;Drug: pioglitazone-placebo;Dietary Supplement: Vitamin E;Drug: Vitamin E-placebo
|
| Outcome Measures: |
Liver Histology (Kleiner's et al Criteria, Hepatology 2005)Number of Participants With Resolution of NASH Without Worsening of Fibrosis;Mean Individual Histological Scores;Individual Histological Scores;Liver Fat by Magnetic Resonance Imaging and Spectroscopy (MRS).;Weight;Body Mass Index;Total Body Fat by DEXA;Plasma AST;Plasma ALT;Fasting Plasma Glucose;Fasting Plasma Insulin;Matsuda Index;Total Cholesterol;Triglycerides;HDL-cholesterol;LDL-cholesterol
|
| Sponsor/Collaborators: |
VA Office of Research and Development
|
| Gender: |
All
|
| Age: |
18 Years70 Years
|
| Phases: |
Phase 4
|
| Enrollment: |
105
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
| Start Date: |
23/10/2009
|
| Completion Date: |
--
|
| Results First Posted: |
11/09/2018
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01002547
|
