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NCT00266019 · ClinicalTrials.gov registry record · Phase 2

Weight Management in Nonalcoholic Steatohepatitis

A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT00266019 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 30 participants.

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The verdict

NCT00266019, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases. The cause of NASH is not completely understood and currently there is no effective treatment for this disease. An effective approach to treatment is needed since without treatment this disease may progress to fibrosis and cirrhosis. Obesity is one of the most important risk factors for NASH and weight reduction is generally recommended as an initial step in its management. However, there are very limited data on the efficacy of weight reduction as a treatment for NASH. Data from uncontrolled trials using poorly defined primary outcome measures and patient populations and nonstandardized weight loss interventions suggest that modest weight loss may improve fatty liver disease. The objective of this project is to conduct a randomized controlled trial of weight reduction in the management of NASH using a combination of diet, exercise, and behavior modification.

Interventions

  • BEHAVIORAL Weight Management (diet, exercise, and behavior modification)

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2005-01
Est. Completion 2007-12
Phase Phase 2

What the Registry Record Tells You About NCT00266019

The ClinicalTrials.gov registry entry for NCT00266019 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Weight Management (diet, exercise, and behavior modification) is the first listed.

NCT00266019 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00266019 about?

NCT00266019 is a clinical study titled "Weight Management in Nonalcoholic Steatohepatitis". Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases. The cause of NASH is not completely understood and currently there is no effective treatment for this disease. An effective approach to treatment is needed since without treatment this disease may progress to fibro...

What is the current status of trial NCT00266019?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2005-01. Estimated completion is 2007-12.

What interventions are being tested in trial NCT00266019?

The interventions under investigation include: Weight Management (diet, exercise, and behavior modification) (BEHAVIORAL).

Who is sponsoring clinical trial NCT00266019?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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