RECRUITING
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Inflammation, Diabetes, Ethnicity and Obesity Cohort
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.
Conditions:
🦠 Obesity 🦠 Diabetes Mellitus 🦠 Pre Diabetes
🗓️ Study Start (Actual) February 2015
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 350
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 January 2017
  • First Submitted that Met QC Criteria 12 January 2017
  • First Posted 16 January 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 March 2024
  • Last Update Posted 7 March 2024
  • Last Verified March 2024
I'm interested ...!!