<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03022682</url>
  </required_header>
  <id_info>
    <org_study_id>14-14248</org_study_id>
    <nct_id>NCT03022682</nct_id>
  </id_info>
  <brief_title>Inflammation, Diabetes, Ethnicity and Obesity Cohort</brief_title>
  <acronym>IDEO</acronym>
  <official_title>Development of a Multi-Ethnic, Multimodal Obesity Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <brief_summary>
    <textblock>
      Obesity affects over one third of US adults (&gt;72 million, with BMI ≥30 kg/m2), and the&#xD;
      proportion of US adults with BMI ≥40 kg/m2 has doubled in the last 20 years. Obesity is&#xD;
      associated with increased mortality through its linkage to comorbidities including diabetes,&#xD;
      hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. Given&#xD;
      its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of&#xD;
      obesity and its consequences is one of the most important problems of our time.&#xD;
&#xD;
      In this proposed study, investigators will recruit participants from a wide range of body&#xD;
      mass index (BMI), ethnicity and Diabetes risk to collect data and blood, stool and adipose&#xD;
      tissue samples in the San Francisco bay area.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Inflammation, Diabetes, Ethnicity and Obesity (IDEO) cohort is recruiting 350 individuals&#xD;
      from various ethnicities, covering a spectrum of weight and Diabetes risk. The study is&#xD;
      looking for participants between the ages of 18-75 years that are healthy with or without&#xD;
      diabetes with a stable weight. The study will also like to include people who are slated to&#xD;
      undergo any type of bariatric surgery for obesity or any other type of abdominal surgery at&#xD;
      UCSF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complete recruitment of IDEO cohort participants to spur novel and creative interactions between investigators that have transformative potential in obesity research.</measure>
    <time_frame>7 years</time_frame>
    <description>Number of biological samples collected</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adipose tissue inflammation and fibrosis</measure>
    <time_frame>7 years</time_frame>
    <description>Quantification of pro-fibrotic and pro-inflammatory markers in the visceral and subcutaneous adipose tissue</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Pre Diabetes</condition>
  <arm_group>
    <arm_group_label>IDEO Cohort</arm_group_label>
    <description>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.&#xD;
Participants also undergo anthropometric measurements, stool collection, blood sample collection for circulating blood cells, serum, and plasma.&#xD;
Dual-energy x-ray absorptiometry (DXA) scan for amount and distribution of body fat as well as bone density is performed.&#xD;
Study participants complete validated questionnaire inventories to measure bio-behavioral issues such as depression, stress, health locus of control, and dietary habits.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, plasma, Adipose tissue, stool&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        IDEO Cohort participants&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will be healthy individuals between the ages of 18-75 years. These&#xD;
             cutoffs are designed to allow inclusion of postmenopausal women, and younger/more&#xD;
             active patients who are increasingly undergoing bariatric surgery.&#xD;
&#xD;
          -  Patients with either diabetes type 2 or the metabolic syndrome will be included in the&#xD;
             cohort.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with chronic kidney disease (&gt; stage 4)&#xD;
&#xD;
          -  Autoimmune/inflammatory disease (e.g., Lupus, Ulcerative Colitis, etc.)&#xD;
&#xD;
          -  Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial&#xD;
             infarction within 3 months of entry&#xD;
&#xD;
          -  Clinically significant liver disease (e.g. Cirrhosis or liver failure)&#xD;
&#xD;
          -  Weight &gt; 450 pounds (DXA scan weight limit)&#xD;
&#xD;
          -  History of organ transplant&#xD;
&#xD;
          -  Treatment with chemotherapy or radiation therapy at the time of enrollment in study.&#xD;
&#xD;
          -  Poorly controlled asthma (participants requiring inhaled glucocorticoids and/or oral&#xD;
             glucocorticoids)&#xD;
&#xD;
          -  Current nasal corticosteroid use (within the past month)&#xD;
&#xD;
          -  Excessive alcohol or substance abuse&#xD;
&#xD;
          -  Current use of anabolic steroids or testosterone for bodybuilding purposes.&#xD;
             Testosterone use is permitted if prescribed for hypogonadism and dose stable for the&#xD;
             past 6 months.&#xD;
&#xD;
          -  Patients actively enrolled in interventional trials involving investigational agents&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Appears unlikely or unable to participate in the required study procedures as assessed&#xD;
             by the investigator, study coordinator or designee.&#xD;
&#xD;
          -  History of abnormal clotting&#xD;
&#xD;
          -  Previous bariatric surgery&#xD;
&#xD;
          -  Anticoagulant use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suneil Koliwad, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suneil Koliwad, MD,PhD</last_name>
      <email>ob.cohort@ucsf.edu</email>
    </contact>
    <contact_backup>
      <last_name>Judy Gonzalez-Vargas, BS</last_name>
      <email>ob.cohort@ucsf.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Diana L Alba, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://koliwadlab.ucsf.edu/ideo-obesity-cohort-0</url>
    <description>Koliwad Lab</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ethnicity</keyword>
  <keyword>inflammation</keyword>
  <keyword>obesity</keyword>
  <keyword>diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03022682
org study id: 14-14248
nct id: NCT03022682
lead sponsor: 
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.
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.
observational model: Cohort
time perspective: Prospective
measure: 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
description: Number of biological samples collected
measure: Adipose tissue inflammation and fibrosis
time frame: 7 years
description: Quantification of pro-fibrotic and pro-inflammatory markers in the visceral and subcutaneous adipose tissue
arm group label: IDEO Cohort
description: 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.
Serum, plasma, Adipose tissue, stool
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Suneil Koliwad, MD,PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: http://koliwadlab.ucsf.edu/ideo-obesity-cohort-0
description: Koliwad Lab
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Obesity
mesh term: Prediabetic State