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Recruiting

NCT Number: NCT02024542

Metabolic Responses 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.

Recruiting

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Key information

Conditions

Morbid Obesity Body Weight Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Mohamed R Ali, MD

PRINCIPAL_INVESTIGATOR

William H Smith, BS, CCRP

CONTACT

[email protected]

916-734-7820

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SURGERY

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.

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed R Ali, MD

CONTACT

[email protected]

916-734-7290

William H Smith, BS, CCRP

CONTACT

[email protected]

916-734-7820

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2035
Study completion
2035
First posted
Dec 31, 2013
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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