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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01002547
The ClinicalTrials.gov registry entry for NCT01002547 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Vitamin E is the first listed.
NCT01002547 reports 0 study locations.
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.
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