LABS-3 Psychosocial

Obesity Clinical Trial

Official title:

Psychosocial Issues and Bariatric Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00582595
• Other study ID #: DK6657_3a
• Secondary ID: U01DK066557
• Status: Active, not recruiting
• Phase: N/A
• First received: December 20, 2007
• Last updated: January 7, 2016
• Start date: January 2007
• Est. completion date: July 2019

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Obesity

Locations

Country	Name	City	State
United States	Neuropsychiatric Research Institute	Fargo	North Dakota
United States	Columbia University Medical Center	New York	New York
United States	Cornell University Medical Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States,