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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by University of California, San Diego.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Mario Chojkier, University of California, San Diego Identifier:
First received: October 17, 2007
Last updated: February 11, 2013
Last verified: July 2010
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
Insulin Resistance
Drug: Fenretinide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by University of California, San Diego:

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

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

Estimated Enrollment: 120
Study Start Date: December 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (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


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

Inclusion Criteria:

  • BMI >30

Exclusion Criteria:

  • Diabetes Requiring Medication
  • Poorly Controlled Co-Morbidities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00546455

Contact: Monique Gagnon, B.A. 858-552-8585 ext 7216
Contact: Maxine Inocencio 858-552-8585 ext 7216

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

Responsible Party: Mario Chojkier, Professor of Medicine, University of California, San Diego Identifier: NCT00546455     History of Changes
Other Study ID Numbers: 061257
Study First Received: October 17, 2007
Last Updated: February 11, 2013

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

Additional relevant MeSH terms:
Insulin Resistance
Nutrition Disorders
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases processed this record on May 22, 2017