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A Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity

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ClinicalTrials.gov Identifier: NCT00546455
Recruitment Status : Unknown
Verified July 2010 by Mario Chojkier, University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : October 19, 2007
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Mario Chojkier, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Drug: Fenretinide Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : December 2007
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : April 2015


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Assessment of the effect on insulin resistance [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Assessment of the biochemical response in cholesterol, glucose and related blood tests. [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI >30

Exclusion Criteria:

  • Diabetes Requiring Medication
  • Poorly Controlled Co-Morbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546455


Contacts
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

Locations
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   
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Mario Chojkier, M.D. University of California, San Diego and San Diego VA Healthcare Medical Center

Responsible Party: Mario Chojkier, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00546455     History of Changes
Other Study ID Numbers: 061257
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: July 2010

Keywords provided by Mario Chojkier, University of California, San Diego:
Obesity
insulin resistance

Additional relevant MeSH terms:
Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases