Metabolic Responses to Bariatric Surgery

University of California (UC) Davis

Status: Enrolling

Conditions: Morbid Obesity

Treatments: Other: Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT02024542

228969

Details and patient eligibility

About

Research the genetic and biomechanical markers of human adipose tissue on patients with morbid obesity. Additional tissue/fluid collection is also gathered during the time of surgery.

Full description

Study participation by invitation after complete pre-surgical work up at UC Davis Health System. Patients will be invited to participate if they meet all inclusion criteria's after completing all necessary clinical visits including lab studies, counseling, and participation in educational programs. During the pre-operative visit patients interested in participation will complete all necessary consent documentation. Pre-operative labs (blood and urine) will be collected along with additional blood, urine, and fecal samples will be collected pre-operatively. During surgery (Roux-en-Y Gastric Bypass surgeries only) tissue collection will include subcutaneous & omental fat, jejunum, and liver biopsy. Post surgery patient will be observed for weight loss and resolution of co-morbidities. At designated times post surgery when lab studies are ordered additional blood/urine samples will be collected and analyzed.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet NIH Criteria for Bariatric Surgery
• Between the Age of 18-55
• Dyslipidemia controlled with medication
• Impaired glucose metabolism or type 2 diabetes

Exclusion criteria

• Uncontrolled Metabolic syndrome (uncontrolled diabetes, htn, dyslipidemia), one or all conditions.

Trial design

500 participants in 2 patient groups

Weight Loss Surgery - Healthy

Description:

Patients consented to participate have met the NIH criteria for Bariatric Surgery and have completed the normal pre-operative work up including nutritional counseling, psychological evaluation, and all necessary studies to rule out other co-morbid conditions prior to surgery. Patients do not have metabolic syndrome.

Treatment:

Other: Surgery

Weight Loss Surgery - Metabolic Syndrome

Description:

Patients consented to participate have met the NIH criteria for Bariatric Surgery and have completed the normal pre-operative work up including nutritional counseling, psychological evaluation, and all necessary studies to rule out other co-morbid conditions prior to surgery. Patients have metabolic syndrome.

Treatment:

Other: Surgery