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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 : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date January 12, 2017
First Posted Date January 16, 2017
Last Update Posted Date February 3, 2023
Study Start Date February 2015
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2021)		 Complete recruitment of IDEO cohort participants to spur novel and creative interactions between investigators that have transformative potential in obesity research. [ Time Frame: 7 years ]
Number of biological samples collected
Original Primary Outcome Measures
 (submitted: January 12, 2017)		 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 ]
Change History
Current Secondary Outcome Measures
 (submitted: October 25, 2021)		 Adipose tissue inflammation and fibrosis [ Time Frame: 7 years ]
Quantification of pro-fibrotic and pro-inflammatory markers in the visceral and subcutaneous adipose tissue
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Inflammation, Diabetes, Ethnicity and Obesity Cohort
Official Title Development of a Multi-Ethnic, Multimodal Obesity Cohort
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum, plasma, Adipose tissue, stool
Sampling Method Non-Probability Sample
Study Population IDEO Cohort participants
Condition
  • Obesity
  • Diabetes Mellitus
  • Pre Diabetes
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 25, 2021)		 350
Original Estimated Enrollment
 (submitted: January 12, 2017)		 145
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03022682
Other Study ID Numbers 14-14248
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University of California, San Francisco
Original Responsible Party Suneil Koliwad, University of California, San Francisco, Assistant Professor of Medicine and Gerold Grodsky, PhD/JAB Chair in Diabetes Research
Current Study Sponsor University of California, San Francisco
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Suneil Koliwad, MD,PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date February 2023