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

Phase 2

Suspended

• Conditions: Obesity; Insulin Resistance
• Interventions: Drug: Placebo; Drug: Fenretinide

• Registration Number: NCT00546455
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-18
• Study First Posted: 2007-10-19
• Study Start: 2007-12
• Primary Completion: 2012-01
• Results First Submitted: 2019-11-27
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-22
• Last Update Submitted: 2021-01-22
• Results First Posted: 2021-02-10
• Last Update Posted: 2021-02-10
• Study Completion: 2099-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• BMI >30

Exclusion Criteria

• Diabetes Requiring Medication
• Poorly Controlled Co-Morbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	Subjects in this cohort will be given placebo.
A	Fenretinide	Subjects in this cohort will be given Fenretinide

Primary Outcome Measures

Name	Time	Method
Assessment of the Effect on Insulin Resistance	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

Name	Time	Method
Assessment of the Biochemical Response in Cholesterol, Glucose and Related Blood Tests.	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.

Trial Locations

Locations (1)

University of California at San Diego Hospitals; 🇺🇸 San Diego, California, United States