Ignite Creation Date:
2024-05-05 @ 11:12 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01289639
Status:
TERMINATED
Last Update Posted:
2017-08-17
First Post:
2011-01-21
Brief Title:
Insulin Resistance in Non-alcoholic Fatty Liver Disease
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Insulin Resistance in Non-alcoholic Fatty Liver Disease Protocol Drug Change From Project Career Development Award CDA-2-044-08S
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment in intervention study Baseline data published
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is designed to investigate the relationship between insulin resistance and non-alcoholic fatty liver disease NAFLD 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
Detailed Description:
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 beta-cell function and body fat distribution Specific Aim 2 To determine in a 6 month placebo-controlled double-blinded treatment study if treatment with pioglitazone 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
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 beta-cell function and body fat distribution Specific Aim 2 To determine in a 6 month placebo-controlled double-blinded treatment study if treatment with pioglitazone 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None