Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT03022682

Conditions

Obesity

Diabetes Mellitus

Pre Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Obesity affects over one third of US adults (>72 million, with BMI ≥30 kg/m2), and the proportion of US adults with BMI ≥40 kg/m2 has doubled in the last 20 years. Obesity is associated with increased mortality through its linkage to comorbidities including diabetes, hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. Given its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of obesity and its consequences is one of the most important problems of our time.

In this proposed study, investigators will recruit participants from a wide range of body mass index (BMI), ethnicity and Diabetes risk to collect data and blood, stool and adipose tissue samples in the San Francisco bay area.

Conditions

Obesity

Diabetes Mellitus

Pre Diabetes

Study ID

NCT03022682

Start date

Feb, 2015

Status verified date

Sep, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants will be healthy individuals between the ages of 18-75 years. These cutoffs are designed to allow inclusion of postmenopausal women, and younger/more active patients who are increasingly undergoing bariatric surgery.
  • Patients with either diabetes type 2 or the metabolic syndrome will be included in the cohort.

Exclusion Criteria:

  • Participants with chronic kidney disease (> stage 4)
  • Autoimmune/inflammatory disease (e.g., Lupus, Ulcerative Colitis, etc.)
  • Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial infarction within 3 months of entry
  • Clinically significant liver disease (e.g. Cirrhosis or liver failure)
  • Weight > 450 pounds (DXA scan weight limit)
  • History of organ transplant
  • Treatment with chemotherapy or radiation therapy at the time of enrollment in study.
  • Poorly controlled asthma (participants requiring inhaled glucocorticoids and/or oral glucocorticoids)
  • Current nasal corticosteroid use (within the past month)
  • Excessive alcohol or substance abuse
  • Current use of anabolic steroids or testosterone for bodybuilding purposes. Testosterone use is permitted if prescribed for hypogonadism and dose stable for the past 6 months.
  • Patients actively enrolled in interventional trials involving investigational agents
  • Pregnant or breast-feeding women
  • Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.
  • History of abnormal clotting
  • Previous bariatric surgery
  • Anticoagulant use
  • Methadone medication

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

IDEO Cohort

Adipose tissue samples are collected from all participants, including aspirational subcutaneous biopsies from nonsurgical participants and excisional biopsies, performed intra-operatively by surgical collaborators as required.

Participants also undergo anthropometric measurements, stool collection, blood sample collection for circulating blood cells, serum, and plasma.

Dual-energy x-ray absorptiometry (DXA) scan for amount and distribution of body fat as well as bone density is performed.

Study participants complete validated questionnaire inventories to measure bio-behavioral issues such as depression, stress, health locus of control, and dietary habits.

Primary outcome measure

  • Complete recruitment of IDEO cohort participants to spur novel and creative interactions between investigators that have transformative potential in obesity research. [ Time Frame: 7 years ]

Central Contacts and Locations

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Suneil Koliwad, MD,PhD

ob.cohort@ucsf.edu

Judy Gonzalez-Vargas, BS

ob.cohort@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • ethnicity
  • inflammation
  • obesity
  • diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-09-08.