NCT00546455SuspendedPhase 2
Phase 2 Study of the Assessment of the Insulin Sensitizing Activity of Fenretinide in Subjects With Insulin Resistance With BMI >30Kg/m2, and Liver Inflammation Related to Non-alcoholic Fatty Liver
University of California, San Diego1 site in 1 country21 target enrollmentStarted: December 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Suspended
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Assessment of the Effect on Insulin Resistance
Study Overview
Brief Summary
Many metabolic complications of obesity are a consequence of abnormal responses of the liver, muscle, and fat to insulin actions. Fenretinide may improve the effects of insulin, preventing metabolic complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Diabetes Requiring Medication
- •Poorly Controlled Co-Morbidities
Arms & Interventions
A
Experimental
Subjects in this cohort will be given Fenretinide
Intervention: Fenretinide (Drug)
B
Placebo Comparator
Subjects in this cohort will be given placebo.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Assessment of the Effect on Insulin Resistance
Time Frame: 30 days
This study was terminated due to expired drug with possibility of re-starting in the future. For this reason the randomization code has not been broken and the data has not been analyzed and there is no way to report the outcome measures.
Secondary Outcomes
- Assessment of the Biochemical Response in Cholesterol, Glucose and Related Blood Tests.(30 days)
Investigators
Mario Chojkier
Professor of Medicine
University of California, San Diego
Study Sites (1)
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