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Clinical Trials/NCT02024542
NCT02024542
Recruiting
Not Applicable

Genetic and Biochemical Characteristics of Medically-Complicated Obesity and Response to Bariatric Surgery

University of California, Davis1 site in 1 country500 target enrollmentFebruary 2011
ConditionsMorbid Obesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbid Obesity
Sponsor
University of California, Davis
Enrollment
500
Locations
1
Primary Endpoint
Tensile Strength of White Adipose Tissue
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
April 2035
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Tensile Strength of White Adipose Tissue

Time Frame: 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.

Study Sites (1)

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