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NCT Number: NCT03022682

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Inflammation Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pre Diabetes Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Diana L Alba, MD

SUB_INVESTIGATOR

Judy Gonzalez-Vargas, BS

CONTACT

[email protected]

Suneil Koliwad, MD,PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Methadone medication

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Adipose tissue inflammation and fibrosis

    Time frame: 7 years

    Quantification of pro-fibrotic and pro-inflammatory markers in the visceral and subcutaneous adipose tissue

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Development of a Multi-Ethnic, Multimodal Obesity Cohort

Acronym: IDEO

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2017
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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