<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/NCT03263390</url>
  </required_header>
  <id_info>
    <org_study_id>170097</org_study_id>
    <nct_id>NCT03263390</nct_id>
  </id_info>
  <brief_title>Modeling the Neurological Basis and Characterizing the Neurological Phenotype of Obesity Using Human Neural Stem Cells</brief_title>
  <official_title>Modeling the Neurological Basis and Characterizing the Neurological Phenotype of Obesity Using Human Neural Stem Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to characterize the neurological basis of obesity and response to surgical&#xD;
      and medical treatment by inducing adult pluripotent stem cells into neuronal cells from&#xD;
      subjects that have demonstrated extreme response to bariatric surgery or pharmacological&#xD;
      treatment for obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will consent subjects who have achieved extreme response to either&#xD;
      bariatric surgery or pharmacologic treatment for obesity and harvest fibroblasts from skin&#xD;
      biopsies, which will be reprogrammed to induced pluripotent stem cells (iPSC). These iPSC's&#xD;
      will then be differentiated into neural progenitor cells, neurons, astrocytes, and microglia&#xD;
      to identify genetic and epigenetic pathways altered in disease-specific neural progenitor&#xD;
      cells of the brain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study terminated by study partners&#xD;
  </why_stopped>
  <start_date type="Actual">October 5, 2017</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>DNA sequencing</measure>
    <time_frame>4 months</time_frame>
    <description>Perform DNA sequencing from skin biopsy progenitor cells</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generate human cell based models of obesity</measure>
    <time_frame>4 months</time_frame>
    <description>Fibroblasts will be expanded in culture and then reprogrammed to hiPSCs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differentiation to human CNS cells</measure>
    <time_frame>4 months</time_frame>
    <description>Disease specific hiPSCs cells will be differentiated into neural progenitor cells, neurons, astrocytes, and microglia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of genetic and epigenetic pathways</measure>
    <time_frame>4 months</time_frame>
    <description>Identify genetic and epigenetic pathways altered in disease-specific neural progenitor cells, neurons, and non-neuronal cells of the brain</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">6</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>Bariatric Surgery</arm_group_label>
    <description>Subjects that have demonstrated extreme response to bariatric surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anti Obesity Medications</arm_group_label>
    <description>Subjects that have demonstrated extreme response to anti obesity pharmacotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatric Surgery</intervention_name>
    <description>Sleeve gastrectomy or Roux-en-Y Gastric Bypass</description>
    <arm_group_label>Bariatric Surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anti Obesity Drugs</intervention_name>
    <description>Response to FDA approved anti obesity medications</description>
    <arm_group_label>Anti Obesity Medications</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fibroblasts, iPSCs, and DNA sequencing information generated from skin biopsies will be&#xD;
      expanded and stored for potential future use.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with obesity who are considered super responders to bariatric surgery or anti&#xD;
        obesity pharmacotherapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of obesity&#xD;
&#xD;
          -  Treatment with bariatric surgery&#xD;
&#xD;
          -  Treatment with anti obesity medications&#xD;
&#xD;
          -  Greater than 70% excess weight loss at least 6 months after surgery&#xD;
&#xD;
          -  Greater than 15% weight loss on anti obesity medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active cancer, not including non-melanoma skin cancer&#xD;
&#xD;
          -  Active eating disorder&#xD;
&#xD;
          -  Use of anti obesity medications in subjects with a history of bariatric surgery&#xD;
&#xD;
          -  Active complication of the upper GI tract in patients with a history of bariatric&#xD;
             surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eduardo Grunvald, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>December 12, 2020</last_update_submitted>
  <last_update_submitted_qc>December 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Eduardo Grunvald</investigator_full_name>
    <investigator_title>Clinical Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Bariatric Surgery</keyword>
  <keyword>Anti Obesity Medications</keyword>
  <keyword>Weight Regulation</keyword>
  <keyword>Pluripotent Stem Cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Obesity Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This is not an intervention trial</ipd_description>
  </patient_data>
  <!-- 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/NCT03263390
org study id: 170097
nct id: NCT03263390
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to characterize the neurological basis of obesity and response to surgical
      and medical treatment by inducing adult pluripotent stem cells into neuronal cells from
      subjects that have demonstrated extreme response to bariatric surgery or pharmacological
      treatment for obesity.
The investigators will consent subjects who have achieved extreme response to either
      bariatric surgery or pharmacologic treatment for obesity and harvest fibroblasts from skin
      biopsies, which will be reprogrammed to induced pluripotent stem cells (iPSC). These iPSC's
      will then be differentiated into neural progenitor cells, neurons, astrocytes, and microglia
      to identify genetic and epigenetic pathways altered in disease-specific neural progenitor
      cells of the brain.
observational model: Case-Only
time perspective: Retrospective
measure: DNA sequencing
time frame: 4 months
description: Perform DNA sequencing from skin biopsy progenitor cells
measure: Generate human cell based models of obesity
time frame: 4 months
description: Fibroblasts will be expanded in culture and then reprogrammed to hiPSCs.
measure: Differentiation to human CNS cells
time frame: 4 months
description: Disease specific hiPSCs cells will be differentiated into neural progenitor cells, neurons, astrocytes, and microglia
measure: Identification of genetic and epigenetic pathways
time frame: 4 months
description: Identify genetic and epigenetic pathways altered in disease-specific neural progenitor cells, neurons, and non-neuronal cells of the brain
arm group label: Bariatric Surgery
description: Subjects that have demonstrated extreme response to bariatric surgery.
arm group label: Anti Obesity Medications
description: Subjects that have demonstrated extreme response to anti obesity pharmacotherapy.
intervention type: Procedure
intervention name: Bariatric Surgery
description: Sleeve gastrectomy or Roux-en-Y Gastric Bypass
arm group label: Bariatric Surgery
intervention type: Drug
intervention name: Anti Obesity Drugs
description: Response to FDA approved anti obesity medications
arm group label: Anti Obesity Medications
Fibroblasts, iPSCs, and DNA sequencing information generated from skin biopsies will be
      expanded and stored for potential future use.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Eduardo Grunvald, MD
role: Principal Investigator
affiliation: UCSD
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Eduardo Grunvald
investigator title: Clinical Professor of Medicine
mesh term: Obesity
mesh term: Obesity, Morbid
mesh term: Anti-Obesity Agents
sharing ipd: No
ipd description: This is not an intervention trial