Clinical trial NCT03022682: Inflammation, Diabetes, Ethnicity and Obesity Cohort
Official title: Development of a Multi-Ethnic, Multimodal Obesity Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Diabetes Mellitus
Pre Diabetes
Keywords: ethnicity
inflammation
obesity
diabetes
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IDEO Cohort participants

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.

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.

Eligibility 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
* GLP-1 Medications:

  * Exenatide (Byetta, Bydureon)
  * Liraglutide (Saxenda, Victoza)
  * Semaglutide (Ozempic, Rybelsus, Wegovy)
  * Dulaglutide (Trulicity)
  * Tirzepatide (Mounjaro)

Primary outcomes:
measure: Complete recruitment of IDEO cohort participants to spur novel and creative interactions between investigators that have transformative potential in obesity research.
timeFrame: 7 years
Secondary outcomes:
measure: Adipose tissue inflammation and fibrosis
timeFrame: 7 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Suneil Koliwad, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.