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LABS-3 Psychosocial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00582595
First received: December 20, 2007
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Obesity
Depression

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 250
Study Start Date: January 2007
Estimated Study Completion Date: June 2014
Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582595

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Cornell University Medical Center
New York, New York, United States, 10021
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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00582595     History of Changes
Other Study ID Numbers: DK6657_3a, U01DK066557
Study First Received: December 20, 2007
Last Updated: November 12, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Obesity
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013