This trial is active, not recruiting.
|Sponsor||University of Pittsburgh|
|Collaborator||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Start date||January 2007|
|End date||July 2019|
|Trial size||250 participants|
|Trial identifier||NCT00582595, DK6657_3a, U01DK066557|
The overall goal of this study is to obtain detailed information that will allow a careful assessment of psychopathology, quality of life and eating behavior pre-surgically and at regular intervals for 2 years after the surgical intervention.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|New York, NY||Columbia University Medical Center||no longer recruiting|
|New York, NY||Cornell University Medical Center||no longer recruiting|
|Fargo, NC||Neuropsychiatric Research Institute||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh Medical Center||no longer recruiting|
Male or female participants at least 18 years old.
Inclusion Criteria: - Male and female patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon. - Previous enrollment in LABS-1 and LABS-2. - BMI at baseline of greater than or equal to 35. Exclusion Criteria: - Informed consent not obtained - Type 1 Diabetes Mellitus - Unlikely to comply with follow-up protocol (ie: geographically inaccessible for study visits) - Unable to communicate with local study staff
|Official title||Psychosocial Issues and Bariatric Surgery|
|Description||Hypotheses 1. Patients undergoing bariatric surgery will experience significant decreases in the rates of psychopathology, in particular depressive illness, and significant improvements in quality of life, post-operatively. 2. Untreated psychopathology that persists well beyond the surgery (e.g. to one-year follow-up) or that develops post-operatively will be associated with less weight loss and decreased quality of life. 3. Untreated psychopathology at the time of bariatric surgery, including affective disorders and substance abuse/alcohol abuse will be associated with increased short-term (e.g. 90 day) complications (e.g. problems with plugging, vomiting, and dehydration) 4. Syndromal/subsyndromal eating disorders prior to surgery including binge eating disorder and night eating syndrome will be associated with eating disorder symptoms and less weight loss at long-term follow-up.|
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