Obesity
Conditions
Keywords
gastric bypass surgery
Brief summary
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.
Interventions
DRUGOrlistat
60mg capsule three times a day for up to 6 months
Sponsors
Albany Medical College
Albany College of Pharmacy and Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients preparing for gastric bypass surgery
Exclusion criteria
* pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 6 months | Weight loss acheived during time on study up to 6 months. |
Secondary
| Measure | Time frame |
|---|---|
| Patient Satisfaction | 6 months |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment 10.14.09 to 12.15.10 Outpatient clinic, Bariatric treatment Center
Participants by arm
| Arm | Count |
|---|---|
| Orlistat 60mg Patients assigned to treatment group for up to 6 months of therapy. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Orlistat 60mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 40.9 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Weight Loss
Weight loss acheived during time on study up to 6 months.
Time frame: 6 months
Population: All patients data who were entered were analyzed, 19 recruited, 15 at 3 months, 9 at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orlistat 60mg | Weight Loss | 2.0 percentage of weight | Standard Deviation 3.4 |
Secondary
Patient Satisfaction
Time frame: 6 months
Population: Patients who completed 6 months of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Orlistat 60mg | Patient Satisfaction | 9 participants |