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Obesity and Nonalcoholic Fatty Liver Disease

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Alcoholic Fatty Liver Disease

Intervention: Niacin (Drug); fenofibrate (Drug); placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Samuel Klein, MD, Principal Investigator, Affiliation: Washington University School of Medicine

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.

Clinical Details

Official title: Obesity and Nonalcoholic Fatty Liver Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome:

Hepatic Insulin Sensitivity Index (HISI)

Percent Increase in Skeletal Muscle Insulin Sensitivity During Insulin Infusion.

Adipose Tissue Insulin Sensitivity

Hepatic Fat Content for Fenofibrate and Niacin Groups

Adipose Tissue Insulin Sensitivity in Fenofibrate and Niacin Groups

Change From Baseline in Skeletal Muscle Insulin Sensitivity

Change From Baseline in Hepatic Insulin Sensitivity Index

Secondary outcome:

Very Low Density Lipoprotein - Triglyceride Production Rate

Change From Baseline in Very Low Density Lipoprotein Apolipoprotein B Production Rate

Change From Baseline in VLDL-Tg Clearance Rate

Change From Baseline in VLDL-Tg Production Rate

Change From Baseline in Very Low-density Lipoprotein Triglyceride Concentration

Detailed description: Obesity is a major risk factor for non-alcoholic fatty liver disease (NAFLD), which represents a spectrum of liver diseases. NAFLD is a major health problem in the US because of its high prevalence and causal relationship with serious liver abnormalities. However, the mechanism(s)responsible for developing NAFLD in obese persons and the effects on liver function are not known. This gap in knowledge has made it difficult to identify effective therapy. The results from these studies will lay the groundwork for the development of novel therapeutic interventions for NAFLD in obese patients.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: All

- 18 - 45 years old

- Class I obesity, i. e. Body Mass Index (BMI) between 30 and 45.

- weight less than 300 lbs.

Exclusion Criteria:

- Active or previous infection with hepatitis B or C, as well as other liver disease.

- History of alcohol abuse

- Diabetes

- Medications that cause liver damage or steatosis.

- Women who are pregnant or lactating.

Locations and Contacts

Washington University School of Medicine, St. Louis, Missouri 63110, United States
Additional Information

Starting date: October 2004
Last updated: July 2, 2010

Page last updated: August 23, 2015

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