CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 target
Drug / intervention
Weight Management (diet, exercise, and behavior modification)behavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00266019
NCT00266019Phase 2Completed

Weight Management in Nonalcoholic Steatohepatitis (NASH)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Dec 15, 2005·Updated Jan 13, 2010

In Brief

A Phase 2 clinical trial evaluating Weight Management (diet, exercise, and behavior modification) for Fatty Liver. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatty Liver
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 15, 2005
Enrollment StartJan 1, 2005
Study CompletionDec 1, 2007
TodayJul 2, 2026
Posted 20.5 years ago

Interventions

Weight Management (diet, exercise, and behavior modification)behavioral