- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00546455
A Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity
January 22, 2021 updated by: Mario Chojkier, University of California, San Diego
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
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92161
- University of California at San Diego Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI >30
Exclusion Criteria:
- Diabetes Requiring Medication
- Poorly Controlled Co-Morbidities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Subjects in this cohort will be given Fenretinide
|
200 mg/day
|
Placebo Comparator: B
Subjects in this cohort will be given placebo.
|
2 capsules/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mario Chojkier, M.D., University of California, San Diego and San Diego VA Healthcare Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2007
Primary Completion (Actual)
January 1, 2012
Study Completion (Anticipated)
January 1, 2099
Study Registration Dates
First Submitted
October 17, 2007
First Submitted That Met QC Criteria
October 18, 2007
First Posted (Estimate)
October 19, 2007
Study Record Updates
Last Update Posted (Actual)
February 10, 2021
Last Update Submitted That Met QC Criteria
January 22, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 061257
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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