Metabolic Responses to Bariatric Surgery

Recruiting

• Conditions: Morbid Obesity
• Interventions: Other: Surgery

• Registration Number: NCT02024542
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2013-12-25
• Study First Submitted QC: 2013-12-25
• Study First Posted: 2013-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2035-04
• Study Completion: 2035-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Weight Loss Surgery - Healthy	Surgery	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.
Weight Loss Surgery - Metabolic Syndrome	Surgery	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.

Primary Outcome Measures

Name	Time	Method
Tensile Strength of White Adipose Tissue	July 2012	During the research tissue samples were compared between healthy obese patients (no diabetes, controlled HTN, no dyslipidemia) with tissue samples collected on non-healthy obese patients (type II diabetes) and using fat collected from mice as a control.

Trial Locations

Locations (1)

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States