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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2010 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Mario Chojkier, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00546455
First received: October 17, 2007
Last updated: February 11, 2013
Last verified: July 2010
  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 2

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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the biochemical response in cholesterol, glucose and related blood tests. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mario Chojkier, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00546455     History of Changes
Other Study ID Numbers: 061257
Study First Received: October 17, 2007
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 21, 2014