Insulin Resistance in Non-alcoholic Fatty Liver Disease

Status Terminated

Clinical Trial Summary

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.

Clinical Trial 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, -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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00252499
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Terminated
Phase	N/A
Start date	October 2005
Completion date	August 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03142633` - MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Recruiting	`NCT04984226` - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD	Phase 2
Recruiting	`NCT05354245` - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)	N/A
Completed	`NCT03383822` - Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance	Phase 1/Phase 2
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Suspended	`NCT03652987` - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT04203238` - Potato Research for Enhancing Metabolic Outcomes	N/A
Recruiting	`NCT03658564` - Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance	N/A
Completed	`NCT04183257` - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics	Phase 4
Completed	`NCT04117802` - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome	N/A
Completed	`NCT03627104` - Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity	N/A
Completed	`NCT05124847` - TREating Pediatric Obesity	N/A
Active, not recruiting	`NCT03288025` - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)	N/A
Completed	`NCT03809182` - Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.	Phase 4
Completed	`NCT01809288` - Identifying Risk for Diabetes and Heart Disease in Women
Completed	`NCT04642482` - Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity	Phase 4
Terminated	`NCT03278236` - Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?	N/A
Not yet recruiting	`NCT06159543` - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes	N/A
Not yet recruiting	`NCT05540249` - Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG	N/A
Withdrawn	`NCT04741204` - Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.