Metabolic Responses to Bariatric Surgery

NCT ID: NCT02024542

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2035-04-30

Brief Summary

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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

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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.

Conditions

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Morbid Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Surgery

Intervention Type OTHER

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.

Surgery

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed R Ali, MD

Role: PRINCIPAL_INVESTIGATOR

University of California Davis Health System

Locations

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University of California Davis Medical Center

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mohamed R Ali, MD

Role: CONTACT

916-734-7290

William H Smith, BS, CCRP

Role: CONTACT

916-734-7820

Facility Contacts

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William H Smith, BS, CCRP

Role: primary

916-734-7820

Related Links

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Other Identifiers

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228969

Identifier Type: -

Identifier Source: org_study_id

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