This trial is active, not recruiting.

Conditions obesity, depression
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

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.