<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/NCT02994186</url>
  </required_header>
  <id_info>
    <org_study_id>161918</org_study_id>
    <nct_id>NCT02994186</nct_id>
  </id_info>
  <brief_title>Examination of Cognitive Function in Obesity and Following Weight Loss</brief_title>
  <official_title>Longitudinal Assessment of Cognitive Function Following Bariatric Surgery or Medical Weight Loss Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lumos Labs, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bariatric surgery is the most effective, long-term treatment for morbid obesity, and&#xD;
      consistent with previous findings, individuals who lose significant weight after surgery also&#xD;
      have improved cognition or &quot;brain function&quot;. The mechanisms behind these cognitive&#xD;
      improvements are currently unknown, but are the focus of much research effort. The goal of&#xD;
      this pilot study is to thoroughly describe these changes in surgical versus medical weight&#xD;
      loss patients over time in a repeated measures fashion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent studies have demonstrated that obesity is associated with decreased cognitive function&#xD;
      and, interestingly, weight loss is associated with improved cognitive function. Bariatric&#xD;
      surgery is the most effective, long-term treatment for morbid obesity, and consistent with&#xD;
      these previous findings, individuals who lose significant weight after surgery appear to have&#xD;
      improved cognition. Previous results have only reported the appearance of cognitive&#xD;
      improvements starting at three months postoperatively, thus, the main focus of this study is&#xD;
      to discover whether cognitive function improvements are seen as early as one month after&#xD;
      bariatric surgery. An acceleration in the onset of cognitive function changes could provide&#xD;
      insight towards the ambiguous underlying neural mechanisms. The benefits of bariatric surgery&#xD;
      extend beyond reversible cognitive deficits. Many of the medical comorbid conditions that&#xD;
      these patients have before surgery (e.g. high blood pressure, high cholesterol, diabetes)&#xD;
      typically resolve prior to any significant weight loss. The mechanisms for these&#xD;
      weight-independent improvements are also undetermined. A secondary focus of this study is to&#xD;
      determine whether or not cognitive function following bariatric surgery also improves prior&#xD;
      to significant weight loss. To test whether cognitive function changes following bariatric&#xD;
      surgery, two cohorts of surgical patients will be recruited as well as another group of&#xD;
      patients undergoing medical weight loss treatment. The goal of this pilot study is to&#xD;
      reproduce and expand upon previous findings that demonstrate cognitive improvements following&#xD;
      bariatric surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 1, 2018</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Cognitive Function Score</measure>
    <time_frame>Repeated Measures Up to 6 Months</time_frame>
    <description>Within group and between group longitudinal measurements will be made using longitudinal regression methods. Baseline as well as 1, 3 and 6 month measurements will be captured either from the time of bariatric surgery or initiation of a supervised medical weight loss program.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive Function Score - Surgical Group Comparison</measure>
    <time_frame>Repeated Measures Up to 6 Months</time_frame>
    <description>Within group and between group longitudinal measurements will be made using longitudinal regression methods. Baseline as well as 1, 3 and 6 month measurements will be captured either from the time of bariatric surgery or initiation of a supervised medical weight loss program. The bariatric operation will be included (Roux-en-Y gastric bypass vs. Vertical Sleeve Gastrectomy) as a variable in the regression model for between and within subjects comparisons in the bariatric surgery group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function Score - Crossover Patients</measure>
    <time_frame>Repeated Measures Up to 6 Months</time_frame>
    <description>There will be a group of patients that will crossover at 6 months from the medical weight loss group to the surgical weight loss group. The cognitive function score in these patients will be compared between treatment groups, as they will effectively be represented in each group.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Surgical Weight Loss</arm_group_label>
    <description>Patients in this group are those that will be undergoing bariatric surgery (either Roux-en-Y gastric bypass or vertical sleeve gastrectomy).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical Weight Loss</arm_group_label>
    <description>Patients in this group are those who are being enrolled in a supervised medical weight loss program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatric Surgery</intervention_name>
    <description>These are patients who will be having either Vertical Sleeve Gastrectomy or Roux-en-Y Gastric Bypass.</description>
    <arm_group_label>Surgical Weight Loss</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical Weight Loss Program</intervention_name>
    <description>These are patients who will be starting a structured medical weight loss program.</description>
    <arm_group_label>Medical Weight Loss</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that will be recruited for this study are those individuals that are pursuing&#xD;
        either medical or surgical weight loss options at the Vanderbilt Centers for Medical and&#xD;
        Surgical Weight Loss.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Within the age rage of 18-70 years&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological disorder or previous injury (e.g. stoke, dementia, seizures, traumatic&#xD;
             brain injury)&#xD;
&#xD;
          -  History of any moderate to severe head injury (i.e. &gt;5 minutes of loss of&#xD;
             consciousness)&#xD;
&#xD;
          -  History of severe psychiatric illness requiring current pharmacologic therapy(e.g.&#xD;
             schizophrenia, bipolar disorder, personality disorders)&#xD;
&#xD;
          -  History of illicit drug or alcohol abuse&#xD;
&#xD;
          -  Known diagnosis of learning or developmental disability&#xD;
&#xD;
          -  Impaired sensory function&#xD;
&#xD;
          -  Any prior suicide attempt&#xD;
&#xD;
          -  Revisional bariatric surgery&#xD;
&#xD;
          -  Current or former tobacco user / smoker&#xD;
&#xD;
          -  Currently pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vance L Albaugh, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Naji N Abumrad, MD</last_name>
    <role>Study Director</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>September 25, 2018</last_update_submitted>
  <last_update_submitted_qc>September 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Vance L. Albaugh, MD, PhD</investigator_full_name>
    <investigator_title>Postdoctoral Fellow and Resident Surgeon</investigator_title>
  </responsible_party>
  <keyword>cognitive function</keyword>
  <keyword>obesity</keyword>
  <keyword>bariatric surgery</keyword>
  <keyword>metabolic surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02994186
org study id: 161918
nct id: NCT02994186
lead sponsor: 
collaborator: 
has dmc: No
Bariatric surgery is the most effective, long-term treatment for morbid obesity, and
      consistent with previous findings, individuals who lose significant weight after surgery also
      have improved cognition or "brain function". The mechanisms behind these cognitive
      improvements are currently unknown, but are the focus of much research effort. The goal of
      this pilot study is to thoroughly describe these changes in surgical versus medical weight
      loss patients over time in a repeated measures fashion.
Recent studies have demonstrated that obesity is associated with decreased cognitive function
      and, interestingly, weight loss is associated with improved cognitive function. Bariatric
      surgery is the most effective, long-term treatment for morbid obesity, and consistent with
      these previous findings, individuals who lose significant weight after surgery appear to have
      improved cognition. Previous results have only reported the appearance of cognitive
      improvements starting at three months postoperatively, thus, the main focus of this study is
      to discover whether cognitive function improvements are seen as early as one month after
      bariatric surgery. An acceleration in the onset of cognitive function changes could provide
      insight towards the ambiguous underlying neural mechanisms. The benefits of bariatric surgery
      extend beyond reversible cognitive deficits. Many of the medical comorbid conditions that
      these patients have before surgery (e.g. high blood pressure, high cholesterol, diabetes)
      typically resolve prior to any significant weight loss. The mechanisms for these
      weight-independent improvements are also undetermined. A secondary focus of this study is to
      determine whether or not cognitive function following bariatric surgery also improves prior
      to significant weight loss. To test whether cognitive function changes following bariatric
      surgery, two cohorts of surgical patients will be recruited as well as another group of
      patients undergoing medical weight loss treatment. The goal of this pilot study is to
      reproduce and expand upon previous findings that demonstrate cognitive improvements following
      bariatric surgery.
observational model: Cohort
time perspective: Prospective
measure: Cognitive Function Score
time frame: Repeated Measures Up to 6 Months
description: Within group and between group longitudinal measurements will be made using longitudinal regression methods. Baseline as well as 1, 3 and 6 month measurements will be captured either from the time of bariatric surgery or initiation of a supervised medical weight loss program.
measure: Cognitive Function Score - Surgical Group Comparison
time frame: Repeated Measures Up to 6 Months
description: Within group and between group longitudinal measurements will be made using longitudinal regression methods. Baseline as well as 1, 3 and 6 month measurements will be captured either from the time of bariatric surgery or initiation of a supervised medical weight loss program. The bariatric operation will be included (Roux-en-Y gastric bypass vs. Vertical Sleeve Gastrectomy) as a variable in the regression model for between and within subjects comparisons in the bariatric surgery group.
measure: Cognitive Function Score - Crossover Patients
time frame: Repeated Measures Up to 6 Months
description: There will be a group of patients that will crossover at 6 months from the medical weight loss group to the surgical weight loss group. The cognitive function score in these patients will be compared between treatment groups, as they will effectively be represented in each group.
arm group label: Surgical Weight Loss
description: Patients in this group are those that will be undergoing bariatric surgery (either Roux-en-Y gastric bypass or vertical sleeve gastrectomy).
arm group label: Medical Weight Loss
description: Patients in this group are those who are being enrolled in a supervised medical weight loss program.
intervention type: Procedure
intervention name: Bariatric Surgery
description: These are patients who will be having either Vertical Sleeve Gastrectomy or Roux-en-Y Gastric Bypass.
arm group label: Surgical Weight Loss
intervention type: Other
intervention name: Medical Weight Loss Program
description: These are patients who will be starting a structured medical weight loss program.
arm group label: Medical Weight Loss
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Vance L Albaugh, MD, PhD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Naji N Abumrad, MD
role: Study Director
affiliation: Vanderbilt University Medical Center
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Vance L. Albaugh, MD, PhD
investigator title: Postdoctoral Fellow and Resident Surgeon
mesh term: Obesity
mesh term: Body Weight
mesh term: Weight Loss
sharing ipd: No