NCT03022682 · University of California, San Francisco
Inflammation, Diabetes, Ethnicity and Obesity Cohort
(IDEO)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Francisco, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 4, 2025 · Source of record for eligibility and locations