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Inflammation, Diabetes, Ethnicity and Obesity Cohort (IDEO)

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ClinicalTrials.gov Identifier: NCT03022682
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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 subjects 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
Obesity Diabetes Mellitus

Detailed Description:
The Inflammation, Diabetes, Ethnicity and Obesity (IDEO) cohort is recruiting 200 individuals from various ethnicities, covering a spectrum of weight and Diabetes risk. The study healthy lean, overweight and obese subjects and people who are slated to undergo any type of bariatric surgery for obesity or any other type of abdominal surgery at UCSF.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Multi-Ethnic, Multimodal Obesity Cohort
Study Start Date : February 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Group/Cohort
IDEO Cohort

Adipose tissue samples are collected from all subjects, including aspirational subcutaneous biopsies from nonsurgical subjects 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 subjects complete validated questionnaire inventories to measure bio-behavioral issues such as depression, stress, health locus of control, and dietary habits.




Primary Outcome Measures :
  1. Complete recruitment of IDEO cohort participants to spur novel and creative interactions between investigators that have transformative potential in obesity research. [ Time Frame: 5 years ]
    number of biological samples collected


Secondary Outcome Measures :
  1. Adipose tissue inflammation and fibrosis [ Time Frame: 5 years ]
    Quantification ofpro-fibrotic and pro-inflammatory markers in the visceral and subcutaneous adipose tissue


Biospecimen Retention:   Samples With DNA
Serum, plasma, Adipose tissue, stool


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
IDEO cohort participants
Criteria

Inclusion Criteria:

  • Subjects 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:

  • Subjects 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 (subjects 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
  • Known HIV infection and/or AIDS
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022682


Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Suneil Koliwad, MD,PhD       ob.cohort@ucsf.edu   
Contact: Fatima Ticas       ob.cohort@ucsf.edu   
Sub-Investigator: Diana L Alba, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Suneil Koliwad, MD,PhD University of California, San Francisco
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03022682    
Other Study ID Numbers: 14-14248
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021
Keywords provided by University of California, San Francisco:
ethnicity
inflammation
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight