Long-term Effects of Bariatric Surgery

The primary goal of LABS-2 is to evaluate the efficacy and safety of bariatric surgery over
a longer term than LABS-1, i.e., more than 30 days. Using a sample of the LABS-1 cohort,
approximately 2,400 patients, will be recruited over 3 years. LABS-2 will include clinical
assessments and detailed interviews and questionnaires pre-operatively and at several
post-operative time points (30 days, 6 months, 12 months following surgery, and annually
thereafter) to assess risks of surgery, and changes in clinical, metabolic, and psychosocial
characteristics in patients, and health care utilization following bariatric surgery.
Detailed data about the surgical procedure and peri- and post-operative care will also be
collected to determine if components of the surgical procedure, and peri-operative and
post-operative care as well as clinical/demographic patient characteristics are associated
with post-operative risks and changes in patient status. Patients enrolled in LABS-2 will
provide blood specimens pre-operatively and post-operatively to address LABS-2 hypotheses
and additional samples will be stored at the NIDDK tissue repository for serologic,
pathologic and genomic testing of other hypotheses.

Inclusion Criteria:

- Patients who are at least 18 years of age and undergo bariatric surgery by a LABS
certified surgeon

- Previous enrollment in LABS-1

- Selected by algorithm to be included in LABS-2

Exclusion Criteria:

- Informed consent not obtained

- Prior bariatric surgery

- Unlikely to comply with follow-up protocol

- Unable to communicate with local study staff