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| Name | Class |
|---|---|
| Albany Medical College | OTHER |
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The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication will be added to the usual standard of care which includes education regarding diet and exercise and monthly meetings with a registered dietician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| orlistat 60mg | Experimental | Patients assigned to treatment group for up to 6 months of therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orlistat | Drug | 60mg capsule three times a day for up to 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Weight loss acheived during time on study up to 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Malone, PhD | Albany College of Pharmacy and Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany College of Pharmacy and Health Sciences | Albany | New York | 12208 | United States |
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Dates of recruitment 10.14.09 to 12.15.10 Outpatient clinic, Bariatric treatment Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Orlistat 60mg | Patients assigned to treatment group for up to 6 months of therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Orlistat 60mg | Patients assigned to treatment group for up to 6 months of therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Weight Loss | Weight loss acheived during time on study up to 6 months. | All patients data who were entered were analyzed, 19 recruited, 15 at 3 months, 9 at 6 months. | Posted | Mean | Standard Deviation | percentage of weight | 6 months |
|
|
6 months
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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 | Orlistat 60mg | Patients assigned to treatment group for up to 6 months of therapy. |
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High drop out rate. Patients did not return to clinic and were lost to follow up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Margaret Malone | Albany College of Pharmacy and Health Sciences | 518 694 7275 | margaret.malone@acphs.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077403 | Orlistat |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| Secondary | Patient Satisfaction | Patients who completed 6 months of the study. | Posted | Number | participants | 6 months |
|
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|
| 0 |
| 19 |
| 0 |
| 19 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |