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NCT00262964 · ClinicalTrials.gov registry record · NA
Obesity and Nonalcoholic Fatty Liver Disease
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT00262964: Completed NA study, sponsored by Washington University School of Medicine.
NCT00262964 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 51 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00262964, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study Summary
The primary goal of this study is to provide a better understanding of: 1) the pathogenesis and pathophysiology of non-alcoholic fatty liver disease (NAFLD) in obese subjects, and 2) the effect of marked weight loss on the histologic and metabolic abnormalities associated with NAFLD. The following hypotheses will be tested: 1. obesity causes hepatic fat accumulation because of excessive fatty acid release from fat tissue and increased free fatty acid availability, 2. increased hepatic (liver) fat content causes insulin-resistant glucose (sugar) production by the liver and altered liver protein synthesis, 3. increased hepatic fat content causes increased lipid (fat) peroxidation, hepatic inflammation, necrosis and fibrosis, and 4. marked weight loss improves NAFLD once patients are weight stable.
Primary Outcome
Hepatic insulin sensitivity, assessed as a function of glucose production rate and plasma insulin concentration. The Hepatic Insulin Sensitivity Index(HISI) is the reciprocal of glucose rate of appearance \[10000/(μmol/min)\] multiplied by insulin concentration\[mU/L\]. The 10000 in the formula is a conventional adjustment so that insulin sensitivity measures are more readable. As yet there is no normal range for HISI, since is a surrogate marker for hepatic insulin sensitivity that has not yet
Interventions
- DRUG Niacin
- DRUG placebo
- DRUG fenofibrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2004-10 |
| Est. Completion | 2008-12 |
| Phase | NA |
What the finished NCT00262964 record still lists
NCT00262964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Niacin is the first listed.
NCT00262964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00262964 about?
NCT00262964 is a clinical study titled "Obesity and Nonalcoholic Fatty Liver Disease". The primary goal of this study is to provide a better understanding of: 1) the pathogenesis and pathophysiology of non-alcoholic fatty liver disease (NAFLD) in obese subjects, and 2) the effect of marked weight loss on the histologic and metabolic abnormalities associated with NAFLD. The following h...
What is the current status of trial NCT00262964?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2004-10. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00262964?
The interventions under investigation include: Niacin (DRUG), placebo (DRUG), fenofibrate (DRUG).
Who is sponsoring clinical trial NCT00262964?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00262964's enrollment target sits among peer trials
51 1279th of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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