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This study was terminated due to expired drug with possibility of re-starting in the future.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Subjects in this cohort will be given Fenretinide |
|
| B | Placebo Comparator | Subjects in this cohort will be given placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenretinide | Drug | 200 mg/day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Chojkier, M.D. | University of California, San Diego and San Diego VA Healthcare Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Diego Hospitals | San Diego | California | 92161 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | A- Fenretinide | Subjects in this cohort will be given Fenretinide Fenretinide: 200 mg/day |
| FG001 | B-Placebo | Subjects in this cohort will be given placebo. Placebo: 2 capsules/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 baseline population analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | A- Fenretinide | Subjects in this cohort will be given Fenretinide Fenretinide: 200 mg/day |
| BG001 | B-Placebo | Subjects in this cohort will be given placebo. Placebo: 2 capsules/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | 30 days |
|
2 months
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 adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A- Fenretinide | Subjects in this cohort will be given Fenretinide Fenretinide: 200 mg/day |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MARIO CHOJKIER | UCSD | 858-552-8585 | 7283 | mchojkier@gmail.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017313 | Fenretinide |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Drug |
2 capsules/day |
|
| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Ethnicity (NIH/OMB) |
|
Subjects in this cohort will be given placebo.
Placebo: 2 capsules/day
|
| 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. | 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. | Posted | 30 days |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | B-Placebo | Subjects in this cohort will be given placebo. Placebo: 2 capsules/day | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |