NCT03022682

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Feb 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Feb 2015Dec 2029

Study Start

First participant enrolled

February 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

14.8 years

First QC Date

January 12, 2017

Last Update Submit

September 2, 2026

Conditions

Keywords

ethnicityinflammationobesitydiabetes

Outcome Measures

Primary Outcomes (1)

  • Complete recruitment of IDEO cohort participants to spur novel and creative interactions between investigators that have transformative potential in obesity research.

    Number of biological samples collected

    7 years

Secondary Outcomes (1)

  • Adipose tissue inflammation and fibrosis

    7 years

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

IDEO Cohort participants

You may qualify if:

  • Patients with either diabetes type 2 or the metabolic syndrome will be included in the cohort.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (2)

  • Alba DL, Abdellatif A, Choi MK, Brown Mayfield SM, Pham TAT, Berrios DI, Rodriguez AE, Ewing M, Figueroa TR, Gonzalez-Vargas J, Zhang N, An Z, Bu D, Deeks SG, Scherer PE, Hunt PW, Koliwad SK. A distinct form of fat fibrosis is linked to insulin resistance in people with HIV. JCI Insight. 2026 Jun 30;11(15):e195922. doi: 10.1172/jci.insight.195922. eCollection 2026 Aug 10.

  • Koppel N, Bisanz JE, Pandelia ME, Turnbaugh PJ, Balskus EP. Discovery and characterization of a prevalent human gut bacterial enzyme sufficient for the inactivation of a family of plant toxins. Elife. 2018 May 15;7:e33953. doi: 10.7554/eLife.33953.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, Adipose tissue, stool

MeSH Terms

Conditions

ObesityDiabetes MellitusGlucose IntoleranceInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperglycemiaPathologic Processes

Study Officials

  • Suneil Koliwad, MD,PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 16, 2017

Study Start

February 1, 2015

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

September 8, 2026

Record last verified: 2026-09

Locations