Menu
Recruiting NCT02024542

Metabolic Responses to Bariatric Surgery

Observational Morbid Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgery.
Who it may be relevant to
Registry conditions: Morbid Obesity. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Genetic and Biochemical Characteristics of Medically-Complicated Obesity and Response to Bariatric Surgery

Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • Tensile Strength of White Adipose Tissue [Time frame: July 2012]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California Davis Medical Center — Sacramento

Identifiers

NCT: NCT02024542 · 228969

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗