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Metabolic Responses to Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02024542
Recruitment Status : Recruiting
First Posted : December 31, 2013
Last Update Posted : April 3, 2023
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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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
Morbid Obesity 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
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic and Biochemical Characteristics of Medically-Complicated Obesity and Response to Bariatric Surgery
Study Start Date : February 2011
Estimated Primary Completion Date : April 2035
Estimated Study Completion Date : April 2035

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Blood, urine, feces, liver, adipose tissue, GI tissue

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients only (currently).
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who present for bariatric surgery to treat morbid obesity.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024542


Contacts
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Contact: Mohamed R Ali, MD 916-734-7290 mrali@ucdavis.edu
Contact: William H Smith, BS, CCRP 916-734-7820 whsmith@ucdavis.edyu

Locations
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United States, California
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: William H Smith, BS, CCRP    916-734-7820    whsmith@ucdavis.edu   
Principal Investigator: Mohamed R Ali, MD         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Mohamed R Ali, MD University of California Davis Health System
More Information
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Additional Information:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02024542    
Other Study ID Numbers: 228969
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: April 3, 2023
Last Verified: March 2023
Keywords provided by University of California, Davis:
Bariatric Surgery
Obesity
Metabolic syndrome
Diabetes
Liver Disease
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overweight
 Overnutrition
Nutrition Disorders
Body Weight