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| Sponsor: | Veterans Medical Research Foundation |
|---|---|
| Collaborator: |
University of California, San Diego |
| Information provided by: | Veterans Medical Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00546455 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Insulin Resistance |
Drug: Fenretinide Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Subjects in this cohort will be given Fenretinide
|
Drug: Fenretinide
200 mg/day
|
|
Placebo Comparator: B
Subjects in this cohort will be given placebo.
|
Drug: Placebo
2 capsules/day
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Monique Gagnon, B.A. | 858-552-8585 ext 7216 | monique.gagnon@va.gov |
| Contact: Maxine Inocencio | 858-552-8585 ext 7216 | minocenc@ucsd.edu |
| United States, California | |
| University of California at San Diego Hospitals | Recruiting |
| San Diego, California, United States, 92161 | |
| Contact: Monique Gagnon, BA 858-552-8585 ext 7216 monique.gagnon@va.gov | |
| Principal Investigator: | Mario Chojkier, M.D. | University of California, San Diego and San Diego VA Healthcare Medical Center |
More Information
| Responsible Party: | Dr. Mario Chojkier, UCSD |
| ClinicalTrials.gov Identifier: | NCT00546455 History of Changes |
| Other Study ID Numbers: | 061257 |
| Study First Received: | October 17, 2007 |
| Last Updated: | March 3, 2011 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
Obesity insulin resistance |
|
Insulin Resistance Obesity Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Fenretinide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs |
