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NCT02024542 Clinical Trial

Metabolic Responses to Bariatric Surgery

Morbid Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02024542
Other study ID # 228969
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2011
Est. completion date April 2035

Study information
Verified date May 2024
Source University of California, Davis
Contact Mohamed R Ali, MD
Phone 916-734-7290
Email mrali@ucdavis.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date April 2035
Est. primary completion date April 2035
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Surgery
Patients wishing to participate in the research will complete all necessary pre-operative work-up labs, testing & counseling, complete and sign the informed consent. During weight loss surgery a small amount of subcutaneous and omental fat will be collected for analysis, with subsequent blood collection post surgery for analysis.

Locations
Country Name City State
United States University of California Davis Medical Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tensile Strength of White Adipose Tissue 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. July 2012
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