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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00252499 |
The purpose of this study is to determine whether nonalcoholic fatty liver disease (NAFLD) is associated with altered peripheral and hepatic insulin sensitivity and to investigate potential mechanisms underlying insulin resistance in NAFLD by determining associations between hepatic and peripheral insulin sensitivity, hepatic steatosis, dyslipidemia, inflammatory cytokines, glucose metabolism, beta-cell function and body fat distribution.
Condition | Intervention |
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Fatty Liver Insulin Resistance |
Drug: rosiglitazone Drug: fenofibrate |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Insulin Resistance in Non-Alcoholic Fatty Liver Disease |
Estimated Enrollment: | 48 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | August 2015 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
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2: Experimental
rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
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Drug: rosiglitazone
PPAR-gamma agonist, insulin sensitizer
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3: Experimental
micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
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Drug: fenofibrate
PPAR-alpha agonist, reduces triglycerides
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NAFLD and nonalcoholic steatohepatitis (NASH) are common liver disorders that are strongly associated with obesity, type 2 diabetes and dyslipidemia. The underlying pathophysiology of fatty infiltration of the liver is thought to be related to insulin resistance, which is an almost universal finding in patients with NAFLD. It is also possible that fat infiltration and inflammation in the liver may impair insulin sensitivity, either locally in the liver, or peripherally via the actions of inflammatory cytokines. We hypothesize that insulin resistance is a major causal factor leading to fat deposition in the liver and NAFLD, and thus interventions aimed at improving insulin sensitivity will result in a reduction of hepatic inflammation and steatosis.
Specific Aim 1: To determine in a cross-sectional study whether NAFLD is associated with altered peripheral and hepatic insulin sensitivity and to study their relationships with hepatic steatosis, dyslipidemia, inflammatory cytokines, glucose metabolism, -cell function and body fat distribution. Specific Aim 2: To determine in a 6 month placebo-controlled double-blinded treatment study if treatment with rosiglitazone, an insulin sensitizer, or fenofibrate, a triglyceride lowering agent, will improve both hepatic as well as peripheral insulin sensitivity and thereby improve hepatic steatosis and inflammation in subjects with NAFLD.
The results of the proposed study will have important implications for our understanding of the mechanisms underlying insulin resistance and abnormalities in lipid and glucose metabolism in subjects with NAFLD and for the design of future studies aimed at the prevention and treatment of this condition.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kristina M Utzschneider, MD | (206) 277-3568 | kutzschn@u.washington.edu |
United States, Washington | |
VA Puget Sound Health Care System, Seattle | Recruiting |
Seattle, Washington, United States, 98108 | |
Contact: Kristina M Utzschneider, MD (206) 277-3568 kutzschn@u.washington.edu | |
Principal Investigator: Kristina Marie Utzschneider, MD |
Principal Investigator: | Kristina Marie Utzschneider, MD | VA Puget Sound Health Care System, Seattle |
Responsible Party: | Department of Veterans Affairs ( Utzschneider, Kristina - Principal Investigator ) |
Study ID Numbers: | CDA-2-044-08S |
Study First Received: | November 9, 2005 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00252499 |
Health Authority: | United States: Federal Government |
beta cell function fenofibrate non-alcoholic steatohepatitis rosiglitazone insulin sensitivity |
Hyperinsulinism Liver Diseases Non-alcoholic steatohepatitis (NASH) Metabolic Diseases Digestive System Diseases Fatty Liver |
Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Procetofen Rosiglitazone Insulin |
Antimetabolites Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Physiological Effects of Drugs Pharmacologic Actions |