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LABS-3 Psychosocial

This study is ongoing, but not recruiting participants.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: December 20, 2007
Last updated: January 7, 2016
Last verified: January 2016
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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychosocial Issues and Bariatric Surgery

Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 250
Study Start Date: January 2007
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Detailed Description:


  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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be selected from bariatric surgical candidates at participating LABS sites in New York and Fargo, ND.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00582595

United States, New York
Cornell University Medical Center
New York, New York, United States, 10021
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Dakota
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58107
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Responsible Party: University of Pittsburgh Identifier: NCT00582595     History of Changes
Other Study ID Numbers: DK6657_3a  U01DK066557 
Study First Received: December 20, 2007
Last Updated: January 7, 2016
Health Authority: United States: Federal Government processed this record on October 21, 2016