Cohort study on obesity, diabetes, and inflammation across different ethnicities
Development of a Multi-Ethnic, Multimodal Obesity Cohort
This study is trying to understand how obesity, diabetes, and inflammation are connected across different ethnic groups by gathering health information and samples from 350 adults with stable weight.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT03022682 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit 350 participants aged 18-75 from various ethnic backgrounds to investigate the relationship between obesity, diabetes, and inflammation. Participants will provide data and biological samples, including blood, stool, and adipose tissue, to better understand the impact of ethnicity and body mass index on diabetes risk. The study focuses on individuals with stable weight, including those scheduled for bariatric or abdominal surgery, to gather comprehensive insights into these interconnected health issues.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18-75, with or without diabetes, who have a stable weight and may include those undergoing bariatric surgery.
Not a fit: Patients with chronic kidney disease, autoimmune diseases, or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of obesity and diabetes, particularly in diverse populations.
How similar studies have performed: Other studies have shown success in exploring the links between obesity, diabetes, and ethnicity, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Francisco, California
- University of California San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Suneil Koliwad, MD,PhD — University of California, San Francisco
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.