NCT02024542

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
108mo left

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Feb 2011Apr 2035

Study Start

First participant enrolled

February 1, 2011

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
21.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2035

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

24.2 years

First QC Date

December 25, 2013

Last Update Submit

May 14, 2026

Conditions

Keywords

Bariatric SurgeryObesityMetabolic syndromeDiabetesLiver Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

SurgeryOTHER

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 - HealthyWeight Loss Surgery - Metabolic Syndrome

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale patients only (currently).
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who present for bariatric surgery to treat morbid obesity.

You may qualify if:

  • Meet NIH Criteria for Bariatric Surgery
  • Between the Age of 18-55
  • Dyslipidemia controlled with medication
  • Impaired glucose metabolism or type 2 diabetes

You may not qualify if:

  • Uncontrolled Metabolic syndrome (uncontrolled diabetes, htn, dyslipidemia), one or all conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine, feces, liver, adipose tissue, GI tissue

MeSH Terms

Conditions

Obesity, MorbidObesityMetabolic SyndromeDiabetes MellitusLiver Diseases

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesDigestive System Diseases

Study Officials

  • Mohamed R Ali, MD

    University of California Davis Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed R Ali, MD

CONTACT

William H Smith, BS, CCRP

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2013

First Posted

December 31, 2013

Study Start

February 1, 2011

Primary Completion (Estimated)

April 1, 2035

Study Completion (Estimated)

April 1, 2035

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations