IDEO: Inflammation, Diabetes, Ethnicity and Obesity Cohort

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT03022682

Collaborator

(none)

350

Enrollment

Location

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Diabetes Mellitus Pre Diabetes

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

Study Type:

Observational

Anticipated Enrollment :

350 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Development of a Multi-Ethnic, Multimodal Obesity Cohort

Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Complete recruitment of IDEO cohort participants to spur novel and creative interactions between investigators that have transformative potential in obesity research. [7 years]
Number of biological samples collected

Secondary Outcome Measures

Adipose tissue inflammation and fibrosis [7 years]
Quantification of pro-fibrotic and pro-inflammatory markers in the visceral and subcutaneous adipose tissue

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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