Insulin Resistance, Obesity
Conditions
Keywords
Obesity, insulin resistance
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.
Interventions
DRUGFenretinide
200 mg/day
DRUGPlacebo
2 capsules/day
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI \>30
Exclusion criteria
* Diabetes Requiring Medication * Poorly Controlled Co-Morbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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 participant flow.
Participants by arm
| Arm | Count |
|---|---|
| A- Fenretinide Subjects in this cohort will be given Fenretinide
Fenretinide: 200 mg/day | 0 |
| B-Placebo Subjects in this cohort will be given placebo.
Placebo: 2 capsules/day | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 30 days
Population: 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
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.
Time frame: 30 days
Population: 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.