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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00546455
• Other study ID #: 061257
• Status: Suspended
• Phase: Phase 2
• Start date: December 2007
• Est. completion date: January 2099

Study information

• Verified date: January 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 21
• Est. completion date: January 2099
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI >30

Exclusion Criteria:

• Diabetes Requiring Medication

• Poorly Controlled Co-Morbidities

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Drug:
• Fenretinide
200 mg/day
• Placebo
2 capsules/day

Locations

Country	Name	City	State
United States	University of California at San Diego Hospitals	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Secondary	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.	30 days