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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 : Suspended (This study was terminated due to expired drug with possibility of re-starting in the future.)
First Posted : October 19, 2007
Results First Posted : February 10, 2021
Last Update Posted : February 10, 2021
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 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
Actual Study Start Date : December 2007
Actual Primary Completion Date : January 2012
Estimated Study Completion Date : January 2099

Resource links provided by the National Library of Medicine


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 ]
    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 Outcome Measures :
  1. Assessment of the Biochemical Response in Cholesterol, Glucose and Related Blood Tests. [ 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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


Locations
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United States, California
University of California at San Diego Hospitals
San Diego, California, United States, 92161
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Mario Chojkier, M.D. University of California, San Diego and San Diego VA Healthcare Medical Center
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Responsible Party: Mario Chojkier, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00546455    
Other Study ID Numbers: 061257
First Posted: October 19, 2007    Key Record Dates
Results First Posted: February 10, 2021
Last Update Posted: February 10, 2021
Last Verified: January 2021
Keywords provided by Mario Chojkier, University of California, San Diego:
Obesity
insulin resistance
Additional relevant MeSH terms:
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Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Fenretinide
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs