ObesityIDEONCT03022682
Inflammation, Diabetes, Ethnicity and Obesity Cohort
An observational study of Obesity and Diabetes Mellitus, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus, Pre Diabetes
- Type of treatment
- Injection or infusion
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: IDEO Cohort participants
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Suneil Koliwad, MD,PhD, ob.cohort@ucsf.edu
Judy Gonzalez-Vargas, BS, ob.cohort@ucsf.edu
About this study
Official title: Development of a Multi-Ethnic, Multimodal Obesity Cohort
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.
Read the detailed description
The Inflammation, Diabetes, Ethnicity and Obesity (IDEO) cohort is recruiting 350 individuals from various ethnicities, covering a spectrum of weight and Diabetes risk. The study is looking for participants between the ages of 18-75 years that are healthy with or without diabetes with a stable weight. The study will also like to include people who are slated to undergo any type of bariatric surgery for obesity or any other type of abdominal surgery at UCSF.
- Conditions
- Obesity, Diabetes Mellitus, Pre Diabetes
- Keywords
- ethnicity, inflammation, obesity, diabetes
- Medical subject headings
- Obesity, Diabetes Mellitus, Glucose Intolerance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 years
Secondary outcomes (1)
Adipose tissue inflammation and fibrosis
Quantification of pro-fibrotic and pro-inflammatory markers in the visceral and subcutaneous adipose tissue
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startFeb 2015
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suneil Koliwad, MD,PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022682
- Sponsor's protocol ID
- 14-14248
- Acronym
- IDEO
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2017
- Last updated
- 8 Sep 2026
- Results posted
- No
Publications
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.
PubMed 42378059Koppel 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.
PubMed 29761785
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multi-Ethnic, Multimodal Obesity Cohort
- ClinicalTrials.gov ID
- NCT03022682
- Acronym / sponsor ID
- IDEO / 14-14248
- Conditions
- Obesity, Diabetes Mellitus, Pre Diabetes
- Keywords
- ethnicity, inflammation, obesity, diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Inflammation, Diabetes, Ethnicity and Obesity (IDEO) cohort is recruiting 350 individuals from various ethnicities, covering a spectrum of weight and Diabetes risk. The study is looking for participants between the ages of 18-75 years that are healthy with or without diabetes with a stable weight. The study will also like to include people who are slated to undergo any type of bariatric surgery for obesity or any other type of abdominal surgery at UCSF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- IDEO Cohort participants
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Number of biological samples collected
1 secondary outcome
Adipose tissue inflammation and fibrosis
Time frame: 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 42378059Alba 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.
- Derived from this study: PubMed 29761785Koppel 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.
- Koliwad LabLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suneil Koliwad, MD,PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes Mellitus, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03022682, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.