Insulin Resistance in Non-alcoholic Fatty Liver Disease

NCT01289639 | Terminated Results

• 1 other identifier: CDA-2-044-08S-2
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver

Keywords

non-alcoholic fatty liver disease; non-alcoholic steatohepatitis; insulin resistance; pioglitazone; fenofibrate

Outcome Measures

Primary Outcomes (1)

• Liver/Spleen Ratio Measured as the Ratio in Hounsfield Units Between the Liver and the Spleen on Computed Tomography (CT) Scan

  6 months

Secondary Outcomes (5)

• Change in Alanine Aminotransferase (ALT) Levels

  0-6 months

• Change in Liver/Spleen Ratio Measure by the Density Ratio in Hounsfield Units Between the Liver and the Spleen by CT

  0-6 months

• Change in Peripheral Insulin Sensitivity

  0-6 months

• Change in Intra-abdominal Fat Area by CT Scan

  0-6 months

• Change in Hepatic Insulin Sensitivity

  0-6 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

matching placebo 1 po qd

Drug: placebo

Fenofibrate

EXPERIMENTAL

micronized fenofibrate 200 mg 1 po qd

Drug: fenofibrate

Pioglitazone

EXPERIMENTAL

pioglitazone 30 mg po qd

Drug: pioglitazone

Interventions

fenofibrate DRUG

micronized fenofibrate 200 mg 1 po qd

Also known as: micronized fenofibrate

Fenofibrate

pioglitazone DRUG

pioglitazone 30 mg po qd

Also known as: Actos

Pioglitazone

placebo DRUG

placebo 1 capsule po qd

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Control subjects: nl liver enzymes and no history of liver disease Case subjects: NAFLD on liver biopsy within the past 3 years or presumed NAFLD with otherwise unexplained elevated alanine aminotransferase (ALT) and fatty liver by computerized tomography (CT) scan or ultrasound
• Able to comply with taking 1 pill a day for 6 months and follow-up safety visits

You may not qualify if:

• Cases: cirrhosis on liver biopsy or by clinical exam or fibrosis score
• Causes of liver dysfunction other than NASH
• Use of medications associated with hepatic steatosis:
• glucocorticoids
• estrogens
• tamoxifen
• amiodarone
• accutane
• sertraline
• Use of medications that cause insulin resistance:
• niacin
• glucocorticoids
• anti-HIV drugs or atypical antipsychotics
• Use of lipid-lowering medications except stable dose statin
• Use of anti-NASH drugs such as ursodeoxycholic acid, betaine milk thistle

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (2)

• Utzschneider KM, Largajolli A, Bertoldo A, Marcovina S, Nelson JE, Yeh MM, Kowdley KV, Kahn SE. Serum ferritin is associated with non-alcoholic fatty liver disease and decreased Beta-cell function in non-diabetic men and women. J Diabetes Complications. 2014 Mar-Apr;28(2):177-84. doi: 10.1016/j.jdiacomp.2013.11.007. Epub 2013 Nov 26.

  PMID: 24360972 RESULT

• Kratz M, Marcovina S, Nelson JE, Yeh MM, Kowdley KV, Callahan HS, Song X, Di C, Utzschneider KM. Dairy fat intake is associated with glucose tolerance, hepatic and systemic insulin sensitivity, and liver fat but not beta-cell function in humans. Am J Clin Nutr. 2014 Jun;99(6):1385-96. doi: 10.3945/ajcn.113.075457. Epub 2014 Apr 16.

  PMID: 24740208 RESULT

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease; Insulin Resistance

Interventions

Fenofibrate; Pioglitazone

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Due to low enrollment, the study was stopped prematurely. Due to the low number of subjects enrolled, statistical analysis was not possible on the intervention study.

Results Point of Contact

• Title: Kristina Utzschneider
• Organization: VA Puget Sound Health Care System

kutzschn@u.washington.edu

206-277-3568

Study Officials

• Kristina M Utzschneider, MD

  VA Puget Sound Health Care System, Seattle

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: February 4, 2011
• Study Start: October 1, 2005
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2014
• Last Updated: August 17, 2017
• Results First Posted: October 20, 2014

Record last verified: 2017-07

Locations

US (1)