Metabolic Responses to Bariatric Surgery

Sponsor
University of California, Davis (Other)
Overall Status
Recruiting
CT.gov ID
NCT02024542
Collaborator
(none)
500
1
170
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Genetic and Biochemical Characteristics of Medically-Complicated Obesity and Response to Bariatric Surgery
Study Start Date :
Feb 1, 2011
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Weight Loss Surgery - Healthy

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.

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.

Weight Loss Surgery - Metabolic Syndrome

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California Davis Medical Center Sacramento California United States 95817

Sponsors and Collaborators

  • University of California, Davis

Investigators

  • Principal Investigator: Mohamed R Ali, MD, University of California Davis Health System

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT02024542
Other Study ID Numbers:
  • 228969
First Posted:
Dec 31, 2013
Last Update Posted:
Feb 2, 2022
Last Verified:
Jan 1, 2022
Keywords provided by University of California, Davis
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2022