Back to resultsA Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity
Primary Purpose
Obesity, Insulin Resistance
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fenretinide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, insulin resistance
Eligibility Criteria
Inclusion Criteria:
- BMI >30
Exclusion Criteria:
- Diabetes Requiring Medication
- Poorly Controlled Co-Morbidities
Sites / Locations
- University of California at San Diego Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Subjects in this cohort will be given Fenretinide
Subjects in this cohort will be given placebo.
Outcomes
Primary Outcome Measures
Assessment of the Effect on Insulin Resistance
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
Assessment of the Biochemical Response in Cholesterol, Glucose and Related Blood Tests.
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.
Full Information
NCT ID
NCT00546455
First Posted
October 17, 2007
Last Updated
January 22, 2021
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00546455
Brief Title
A Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity
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 Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Suspended
Why Stopped
This study was terminated due to expired drug with possibility of re-starting in the future.
Study Start Date
December 2007 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2099 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
Obesity, insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Subjects in this cohort will be given Fenretinide
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Subjects in this cohort will be given placebo.
Intervention Type
Drug
Intervention Name(s)
Fenretinide
Intervention Description
200 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 capsules/day
Primary Outcome Measure Information:
Title
Assessment of the Effect on Insulin Resistance
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Assessment of the Biochemical Response in Cholesterol, Glucose and Related Blood Tests.
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI >30
Exclusion Criteria:
Diabetes Requiring Medication
Poorly Controlled Co-Morbidities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Chojkier, M.D.
Organizational Affiliation
University of California, San Diego and San Diego VA Healthcare Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Diego Hospitals
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity
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