Study Stopped
Protocol drug change required new clinicaltrails.gov entry
Insulin Resistance in Non-alcoholic Fatty Liver Disease
1 other identifier
interventional
13
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
April 11, 2014
CompletedAugust 20, 2014
August 1, 2014
4.8 years
November 9, 2005
November 12, 2013
August 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Liver/Spleen Ratio at 6 Months
Liver fat was estimated by non-contrast CT scan measuring the density ratio between the liver and spleen by Hounsfield units (liver/spleen ratio), which has been previously correlated with liver fat quantification by magnetic resonance spectroscopy.Ten separate measurements equally distributed throughout the liver and spleen were obtained and the Hounsfield units averaged. In subjects with more than one slice through the liver and spleen, the values for all slices were averaged.
6 months
Secondary Outcomes (5)
Change in Alanine Aminotransferase (ALT) Levels From Baseline to 6 Months
6 months
Change in the Liver Spleen Ratio by CT Scan From Baseline to 6 Months as a Measure of Fat in the Liver
6 months
Change in Peripheral Insulin Sensitivity From Baseline to 6 Months
6 months
Changes in Intra-abdominal Fat Area From Baseline to 6 Months
6 months
Change in Hepatic Insulin Sensitivity From Baseline to 6 Months
6 months
Study Arms (3)
Placebo Arm
PLACEBO COMPARATORmatching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
Rosiglitazone Arm
EXPERIMENTALrosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
Fenofibrate Arm
EXPERIMENTALmicronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
Interventions
placebo tablets that are matched to look like rosiglitazone
placebo matched to look like fenofibrate tablets
Eligibility Criteria
You may qualify if:
- Age 18-80 years old Controls:
- otherwise healthy Case subjects: NAFLD on liver biopsy within the past 3 years or presumed NAFLD with otherwise unexplained elevated ALT and fatty liver by CT or ultrasound
- Able to comply with taking 3 pills a day for 6 months and follow-up safety visits
You may not qualify if:
- Controls:
- history or evidence of hepatic steatosis
- 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
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108, United States
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: 24360972RESULTKratz 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: 24740208RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to recruitment difficulties and concerns about the safety of thiazolidinediones, recruitment was stopped without achieving adequate sample size (16/arm). Thus, no definitive conclusions can be made about the study medications.
Results Point of Contact
- Title
- Kristina Utzschneider, MD
- Organization
- VA Puget Sound Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
Kristina Marie Utzschneider, MD
VA Puget Sound Health Care System, Seattle
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2005
First Posted
November 11, 2005
Study Start
October 1, 2005
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
August 20, 2014
Results First Posted
April 11, 2014
Record last verified: 2014-08