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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 : January 16, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Suneil Koliwad, 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.

Condition or disease
Obesity Diabetes Mellitus

Detailed Description:
The Inflammation, Diabetes, Ethnicity and Obesity (IDEO) cohort is recruiting 145 lean and obese individuals from three ethnicities, covering a spectrum of obesity and T2DM risk. Specifically, the cohort will include: 1) 45 obese subjects, including individuals each from three ethnic groups; Caucasian, Hispanic/Latino, and Chinese; 2) 45 subjects who are slated to undergo any type of bariatric surgery for obesity (20 individuals each from the three ethnic groups above); and 3) 55 lean controls, including individuals from each ethnicity.

Study Type : Observational
Estimated Enrollment : 145 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 2020
Estimated Study Completion Date : December 2020

Group/Cohort
IDEO Cohort
IDEO is recruiting 145 lean and obese individuals from three ethnicities, covering a spectrum of obesity and T2DM risk. The cohort will include three ethnic groups; Caucasian, Hispanic/Latino, and Chinese and also include subjects slated to undergo bariatric surgery. 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 ]

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:   25 Years to 65 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 defined (lean and obese) from three defined ethnic groups; Caucasian, Hispanic/Latino, and Chinese.
  • Subjects will be between the ages of 25-65 years. These cutoffs are designed to allow inclusion of postmenopausal women, and younger/more active patients who are increasingly undergoing bariatric surgery.
  • BMI criteria for both surgical and nonsurgical obese patients and lean "controls" are as follows: Obese patients: BMI > 30 with standard comorbidities. For Chinese individual BMI cutoff for obesity is >27. Lean controls: BMI < 30 but BMI >18.5
  • Patients with either diabetes type 2 or the metabolic syndrome will be included in the cohort.

Exclusion Criteria:

  • Subjects with chronic kidney disease (> stage 3), chronic infections, autoimmune diseases.
  • Subjects with symptomatic heart failure or CAD, cirrhosis or liver failure.
  • Tobacco abuse
  • Subjects on glucocorticoids, immunosuppressants [ tacrolimus, cellcept] and PPAR-gamma agonist will be excluded from the study.

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
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Suneil Koliwad, MD,PhD    415-476-4661    ob.cohort@ucsf.edu   
Contact: Diana Alba, MD    415-476-9847    ob.cohort@ucsf.edu   
Sub-Investigator: Diana L Alba, MD         
Sponsors and Collaborators
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
Responsible Party: Suneil Koliwad, Assistant Professor of Medicine and Gerold Grodsky, PhD/JAB Chair in Diabetes Research, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03022682     History of Changes
Other Study ID Numbers: 14-14248
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017

Keywords provided by Suneil Koliwad, University of California, San Francisco:
ethnicity
inflammation

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms