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NCT01002547 · ClinicalTrials.gov registry record · Phase 4
Prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanics With Diabetes Mellitus Type 2 (T2DM) and Role of Treatment
A Phase 4 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 105
- Enrollment target
NCT01002547: Completed Phase 4 study, sponsored by VA Office of Research and Development.
NCT01002547 is a Phase 4 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 105 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01002547, a Phase 4 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 105 participants
- Enrollment target
Study Summary
Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition frequently associated with type 2 diabetes (T2DM) and characterized by insulin resistance and hepatic fat accumulation. Liver fat may range from simple steatosis to severe steatohepatitis with necroinflammation and variable degrees of fibrosis (nonalcoholic steatohepatitis or NASH). Up to 40% of patients with NAFLD develop NASH in recent series. Risk factors for progression to NASH are unclear, but appears to be more common and progress more rapidly in older individuals, and in the presence of obesity and T2DM. Because the VA population in San Antonio, Texas, frequently combine these risk factors for NASH it was felt that a study targeting this very high-risk population was needed. This study will establish the long-term efficacy (primary endpoint: liver histology) and safety of pioglitazone for the treatment of VA patients with T2DM and NASH. All patients diagnosed with NASH will be offered lifestyle modification/weight loss (current standard of care) while being randomized to pioglitazone, vitamin E or placebo for up to 3 years. We believe that in such a high-risk population for complications from NASH, a substantial benefit may be expected from early detection and treatment. Specifically, the arms are: a) pioglitazone + vitamin E; b) vitamin E + placebo of pioglitazone; c) placebo of both. Patients are randomized to one of these 3 arms, and followed in a double-blind fashion for up to 18 months. Patients are then offered to continue into an open-label phase with pioglitazone + vitamin E or vitamin E alone for another 18 months.
Primary Outcome
Number of patients with reduction of at least 2 points in the nonalcoholic fatty liver disease activity score (NAS) (with reduction in at least 2 different histological categories) without worsening of fibrosis. NAS is the sum of the separate scores for steatosis (0-3), hepatocellular ballooning (0-2) and lobular inflammation (0-3), and ranges from 0-8 . The scoring system is based on the following grading: Steatosis: 0 = \<5%; 1 = 5-33%; 2 = \>33-66%; 3 = \>66%. Lobular Inflammation: 0 = No f
Interventions
- DIETARY_SUPPLEMENT Vitamin E
- DRUG pioglitazone
- DRUG pioglitazone-placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2010-06-24 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 4 |
What the finished NCT01002547 record still lists
NCT01002547 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Vitamin E is the first listed.
NCT01002547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01002547 about?
NCT01002547 is a clinical study titled "Prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanics With Diabetes Mellitus Type 2 (T2DM) and Role of Treatment". Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition frequently associated with type 2 diabetes (T2DM) and characterized by insulin resistance and hepatic fat accumulation. Liver fat may range from simple steatosis to severe steatohepatitis with necroinflammation and variable degree...
What is the current status of trial NCT01002547?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2010-06-24. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT01002547?
The interventions under investigation include: Vitamin E (DIETARY_SUPPLEMENT), pioglitazone (DRUG), pioglitazone-placebo (DRUG).
Who is sponsoring clinical trial NCT01002547?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01002547's enrollment target sits among peer trials
105 749th of 2000 higher than 1,247 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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