- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02024542
Metabolic Responses to Bariatric Surgery
May 14, 2026 updated by: University of California, Davis
Genetic and Biochemical Characteristics of Medically-Complicated Obesity and Response to Bariatric Surgery
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.
Study Overview
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 Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed R Ali, MD
- Phone Number: 916-734-7290
- Email: mrali@ucdavis.edu
Study Contact Backup
- Name: William H Smith, BS, CCRP
- Phone Number: 916-734-7820
- Email: whsmith@ucdavis.edyu
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- Recruiting
- University of California Davis Medical Center
-
Contact:
- William H Smith, BS, CCRP
- Phone Number: 916-734-7820
- Email: whsmith@ucdavis.edu
-
Principal Investigator:
- Mohamed R Ali, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who present for bariatric surgery to treat morbid obesity.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
July 2012
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed R Ali, MD, University of California Davis Health System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Estimated)
April 1, 2035
Study Completion (Estimated)
April 1, 2035
Study Registration Dates
First Submitted
December 25, 2013
First Submitted That Met QC Criteria
December 25, 2013
First Posted (Estimated)
December 31, 2013
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
May 14, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Digestive System Diseases
- Glucose Metabolism Disorders
- Insulin Resistance
- Hyperinsulinism
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Metabolic Syndrome
- Diabetes Mellitus
- Liver Diseases
- Obesity, Morbid
- Surgical Procedures, Operative
Other Study ID Numbers
- 228969
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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