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
|Condition or disease||Intervention/treatment||Phase|
|Obesity Insulin Resistance||Drug: Fenretinide Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Subjects in this cohort will be given Fenretinide
Placebo Comparator: B
Subjects in this cohort will be given placebo.
- 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.
- 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.
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
|United States, California|
|University of California at San Diego Hospitals|
|San Diego, California, United States, 92161|
|Principal Investigator:||Mario Chojkier, M.D.||University of California, San Diego and San Diego VA Healthcare Medical Center|