<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/NCT04429386</url>
  </required_header>
  <id_info>
    <org_study_id>IRB#13-001552</org_study_id>
    <nct_id>NCT04429386</nct_id>
  </id_info>
  <brief_title>Brain Gut Axis Changes After Bariatric Surgery and Their Relationship to Weight Loss</brief_title>
  <official_title>Brain Responses Associated With Ingestive Behavior in Obese Women: the Effects of Bariatric Surgery, and Their Association With Behavioral, Satiety Signal Responses and Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</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>
      Assessing the changes in the brain-gut axis after weight loss surgery and their relationship&#xD;
      with weight loss and changes in eating behaviors.&#xD;
&#xD;
      Obese women undergoing weight loss surgery will be recruited to participate in the study.&#xD;
      These individuals will undergo a screening visit and 4 study visits. The study visits will&#xD;
      occur before, and at 1-, 6- and 12 months after the weight loss surgery. Each study visit&#xD;
      will include evaluation of brain function (fMRI), anthropometrics, blood and stool samples&#xD;
      and eating behaviors questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assessing the changes in the brain-gut axis after weight loss surgery and their relationship&#xD;
      with weight loss and changes in eating behaviors.&#xD;
&#xD;
      Obese women undergoing weight loss surgery will be recruited to participate in the study.&#xD;
      These subjects will undergo a screening visit and 4 study visits. The study visits will occur&#xD;
      before, and at 1-, 6- and 12 months after the weight loss surgery. Each study visit will&#xD;
      include evaluation of brain function (fMRI), anthropometrics, blood samples (gut hormones,&#xD;
      cytokines, metabolomics ) and stool samples (16S RNA and Metabolomics) and eating behaviors&#xD;
      questionnaires (YFAS, TFEQ, food cravings/preferences scales, 3-day food food intake records)&#xD;
&#xD;
      Primary outcomes: weight loss after surgery and changes in eating behaviors scales (YFAS,&#xD;
      TFEQ) , metabolomics, appetite related hormones and gut microbiome (16S RNA) Secondary&#xD;
      outcomes: changes in brain function (fMRI/MRS), diet (3-day food intake records) and&#xD;
      inflammatory markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2014</start_date>
  <completion_date type="Actual">April 15, 2021</completion_date>
  <primary_completion_date type="Actual">April 15, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of excess weight loss at 6 months</measure>
    <time_frame>Measured at 6-months after bariatric surgery</time_frame>
    <description>Measure of weight loss, it is calculated using the following formula: preoperative weight - weight at the follow-up visit)/(preoperative weight - Ideal body weight *100. Greater values mean greater weight loss (better).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of excess weight loss at 12 months</measure>
    <time_frame>Measured at 12-months after bariatric surgery</time_frame>
    <description>Measure of weight loss, it is calculated using the following formula: preoperative weight - weight at the follow-up visit)/(preoperative weight - Ideal body weight *100. Greater values mean greater weight loss (better). Greater values are better.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Yale Food Addiction Scale score at 6 months</measure>
    <time_frame>Measured at baseline and at 6-months after the bariatric surgery</time_frame>
    <description>Yale Food Addiction Scale that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Yale Food Addiction Scale score at 12 months</measure>
    <time_frame>Measured at baseline and at 12-months after the bariatric surgery</time_frame>
    <description>Yale Food Addiction Scale that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Three-Factor Eating Questionnaire score at 6-months</measure>
    <time_frame>Measured at baseline and 6-months after the bariatric surgery</time_frame>
    <description>Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Three-Factor Eating Questionnaire score at 12-months</measure>
    <time_frame>Measured at baseline and 12-months after the bariatric surgery</time_frame>
    <description>Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in diet (3-day food intake record) at 6-months.</measure>
    <time_frame>Measured at baseline and at 6-months after the bariatric surgery</time_frame>
    <description>3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in diet (3-day food intake record) at 12-months.</measure>
    <time_frame>Measured at baseline and at 12-months after the bariatric surgery</time_frame>
    <description>3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood levels of Ghrelin at 6-months</measure>
    <time_frame>Measured at baseline and at 6-months after the bariatric surgery</time_frame>
    <description>Serum levels of Ghrelin. Units of gut hormones include Ghrelin in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood levels of Ghrelin at 12-months</measure>
    <time_frame>Measured at baseline and at 12-months after the bariatric surgery</time_frame>
    <description>Serum levels of Ghrelin. Units of gut hormones include Ghrelin in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood levels of glucagon-like peptide (GLP)-1 at 6-months</measure>
    <time_frame>Measured at baseline and at 6-months after the bariatric surgery</time_frame>
    <description>Serum levels of glucagon-like peptide (GLP)-1. Units of gut hormones include GLP-1 in pmol/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood levels of glucagon-like peptide (GLP)-1 at 12-months</measure>
    <time_frame>Measured at baseline and at 12-months after the bariatric surgery</time_frame>
    <description>Serum levels of glucagon-like peptide (GLP)-1. Units of gut hormones include GLP-1 in pmol/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood levels of Peptide YY at 6-months</measure>
    <time_frame>Measured at baseline and at 6-months after the bariatric surgery</time_frame>
    <description>Serum levels of peptideYY(PYY). Units of Peptide YY in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood levels of Peptide YY at 12-months</measure>
    <time_frame>Measured at baseline and at 12-months after the bariatric surgery</time_frame>
    <description>Serum levels of peptideYY(PYY). Units of Peptide YY in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood levels of insulin at 6-months</measure>
    <time_frame>Measured at baseline and at 6-months after the bariatric surgery</time_frame>
    <description>Serum levels of insulin. Units of gut hormones include insulin in ulu/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood levels of insulin at 12-months</measure>
    <time_frame>Measured at baseline and at 12-months after the bariatric surgery</time_frame>
    <description>Serum levels of insulin. Units of gut hormones include insulin in ulu/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood levels of leptin at 6-months</measure>
    <time_frame>Measured at baseline and at 6-months after the bariatric surgery</time_frame>
    <description>Serum levels of leptin. Units of gut hormones include Leptin in ng/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in blood levels of leptin at 12-months</measure>
    <time_frame>Measured at baseline and at 12-months after the bariatric surgery</time_frame>
    <description>Serum levels of leptin. Units of gut hormones include Leptin in ng/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in gut microbiome at 6 months</measure>
    <time_frame>Measured at baseline and at 6-months after the bariatric surgery</time_frame>
    <description>High-Throughput Microbiome Sequencing for sequencing of the 16S ribosomal RNA. Output sequences are classified as domain, phylum, family and genus to species, depending on the depth of reliable classifier assignments ribosomal RNA (rRNA) gene as the genetic marker to study bacterial phylogeny and taxonomy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in gut microbiome at 12 months</measure>
    <time_frame>Measured at baseline and at 12-months after the bariatric surgery</time_frame>
    <description>High-Throughput Microbiome Sequencing for sequencing of the 16S ribosomal RNA. Output sequences are classified as domain, phylum, family and genus to species, depending on the depth of reliable classifier assignments ribosomal RNA (rRNA) gene as the genetic marker to study bacterial phylogeny and taxonomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 6 months</measure>
    <time_frame>Measured at baseline and at 6-months after the bariatric surgery</time_frame>
    <description>Functional brain images will be obtained using established acquisition protocols for resting state and evoked brain responses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 12 months</measure>
    <time_frame>Measured at baseline and at 12-months after the bariatric surgery</time_frame>
    <description>Functional brain images will be obtained using established acquisition protocols for resting state and evoked brain responses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Inflammatory markers at 6 months</measure>
    <time_frame>Measured at baseline and at 6-months after the bariatric surgery</time_frame>
    <description>Serum levels of adipokines and inflammatory cytokines. Units include: Adiponectin in pg/ml, Interleukin 1β in pg/ml , Interleukin 6 in pg/ml, Lipopolysaccharide in pg/ml, tumor-necrosis-factor TNF-α in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Inflammatory markers at 12 months</measure>
    <time_frame>Measured at baseline and at 12-months after the bariatric surgery</time_frame>
    <description>Serum levels of adipokines and inflammatory cytokines. Units include: Adiponectin in pg/ml, Interleukin 1β in pg/ml , Interleukin 6 in pg/ml, Lipopolysaccharide in pg/ml, tumor-necrosis-factor TNF-α in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in metabolite concentrations at 6 months.</measure>
    <time_frame>Measured at baseline and at 6-months after the bariatric surgery</time_frame>
    <description>Differences in blood metabolite concentrations measured by mass spectrometry, comparing metabolite concentrations from obese patients at baseline and after bariatric surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in metabolite concentrations at 12 months.</measure>
    <time_frame>Measured at baseline and at 12-months after the bariatric surgery</time_frame>
    <description>Differences in blood metabolite concentrations measured by mass spectrometry, comparing metabolite concentrations from obese patients at baseline and after bariatric surgery.</description>
  </secondary_outcome>
  <enrollment type="Actual">22</enrollment>
  <condition>Obesity</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatric surgery</intervention_name>
    <description>Laparoscopic bariatric surgery including gastric bypass and sleeve gastrectomy</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool samples for 16S RNA analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We will include obese women undergoing bariatric surgery as part of standard medical care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women, age 18-55 years&#xD;
&#xD;
          -  Eligible and approved for undergoing laparoscopic gastric bypass (LRYGB) or&#xD;
             laparoscopic sleeve gastrectomy (LSG) following the Guidelines for Clinical&#xD;
             application of Laparoscopic Bariatric Surgery by of American Gastrointestinal and&#xD;
             Endoscopic Surgeons (SAGES)&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous major gastrointestinal surgery including weight loss surgery (partial or&#xD;
             complete resection of stomach and/or small bowel, Whipple procedure, etc)&#xD;
&#xD;
          -  Use of medications known to affect hunger, satiety, or intestinal motility.&#xD;
&#xD;
          -  Unwillingness or inability to give informed consent&#xD;
&#xD;
          -  Any contraindication to undergo MRI&#xD;
&#xD;
          -  Current or past alcohol or drug abuse problem or smoking&#xD;
&#xD;
          -  Pregnancy, lactating or post partum less than 12 months&#xD;
&#xD;
          -  Body weight at enrollment greater than 350 lbs.&#xD;
&#xD;
          -  Current use of insulin and or insulin dependent diabetes&#xD;
&#xD;
          -  Renal insufficiency, retinopathy, or neuropathy.&#xD;
&#xD;
          -  Post menopausal (defined as no menses for 12 consecutive months)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>August 11, 2021</last_update_submitted>
  <last_update_submitted_qc>August 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04429386
org study id: IRB#13-001552
nct id: NCT04429386
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assessing the changes in the brain-gut axis after weight loss surgery and their relationship
      with weight loss and changes in eating behaviors.

      Obese women undergoing weight loss surgery will be recruited to participate in the study.
      These individuals will undergo a screening visit and 4 study visits. The study visits will
      occur before, and at 1-, 6- and 12 months after the weight loss surgery. Each study visit
      will include evaluation of brain function (fMRI), anthropometrics, blood and stool samples
      and eating behaviors questionnaires.
Assessing the changes in the brain-gut axis after weight loss surgery and their relationship
      with weight loss and changes in eating behaviors.

      Obese women undergoing weight loss surgery will be recruited to participate in the study.
      These subjects will undergo a screening visit and 4 study visits. The study visits will occur
      before, and at 1-, 6- and 12 months after the weight loss surgery. Each study visit will
      include evaluation of brain function (fMRI), anthropometrics, blood samples (gut hormones,
      cytokines, metabolomics ) and stool samples (16S RNA and Metabolomics) and eating behaviors
      questionnaires (YFAS, TFEQ, food cravings/preferences scales, 3-day food food intake records)

      Primary outcomes: weight loss after surgery and changes in eating behaviors scales (YFAS,
      TFEQ) , metabolomics, appetite related hormones and gut microbiome (16S RNA) Secondary
      outcomes: changes in brain function (fMRI/MRS), diet (3-day food intake records) and
      inflammatory markers.
observational model: Case-Only
time perspective: Prospective
measure: Percentage of excess weight loss at 6 months
time frame: Measured at 6-months after bariatric surgery
description: Measure of weight loss, it is calculated using the following formula: preoperative weight - weight at the follow-up visit)/(preoperative weight - Ideal body weight *100. Greater values mean greater weight loss (better).
measure: Percentage of excess weight loss at 12 months
time frame: Measured at 12-months after bariatric surgery
description: Measure of weight loss, it is calculated using the following formula: preoperative weight - weight at the follow-up visit)/(preoperative weight - Ideal body weight *100. Greater values mean greater weight loss (better). Greater values are better.
measure: Change in Yale Food Addiction Scale score at 6 months
time frame: Measured at baseline and at 6-months after the bariatric surgery
description: Yale Food Addiction Scale that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).
measure: Change in Yale Food Addiction Scale score at 12 months
time frame: Measured at baseline and at 12-months after the bariatric surgery
description: Yale Food Addiction Scale that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).
measure: Change in Three-Factor Eating Questionnaire score at 6-months
time frame: Measured at baseline and 6-months after the bariatric surgery
description: Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).
measure: Change in Three-Factor Eating Questionnaire score at 12-months
time frame: Measured at baseline and 12-months after the bariatric surgery
description: Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).
measure: Change in diet (3-day food intake record) at 6-months.
time frame: Measured at baseline and at 6-months after the bariatric surgery
description: 3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients
measure: Change in diet (3-day food intake record) at 12-months.
time frame: Measured at baseline and at 12-months after the bariatric surgery
description: 3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients
measure: Changes in blood levels of Ghrelin at 6-months
time frame: Measured at baseline and at 6-months after the bariatric surgery
description: Serum levels of Ghrelin. Units of gut hormones include Ghrelin in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
measure: Changes in blood levels of Ghrelin at 12-months
time frame: Measured at baseline and at 12-months after the bariatric surgery
description: Serum levels of Ghrelin. Units of gut hormones include Ghrelin in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
measure: Changes in blood levels of glucagon-like peptide (GLP)-1 at 6-months
time frame: Measured at baseline and at 6-months after the bariatric surgery
description: Serum levels of glucagon-like peptide (GLP)-1. Units of gut hormones include GLP-1 in pmol/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
measure: Changes in blood levels of glucagon-like peptide (GLP)-1 at 12-months
time frame: Measured at baseline and at 12-months after the bariatric surgery
description: Serum levels of glucagon-like peptide (GLP)-1. Units of gut hormones include GLP-1 in pmol/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
measure: Changes in blood levels of Peptide YY at 6-months
time frame: Measured at baseline and at 6-months after the bariatric surgery
description: Serum levels of peptideYY(PYY). Units of Peptide YY in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
measure: Changes in blood levels of Peptide YY at 12-months
time frame: Measured at baseline and at 12-months after the bariatric surgery
description: Serum levels of peptideYY(PYY). Units of Peptide YY in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
measure: Changes in blood levels of insulin at 6-months
time frame: Measured at baseline and at 6-months after the bariatric surgery
description: Serum levels of insulin. Units of gut hormones include insulin in ulu/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
measure: Changes in blood levels of insulin at 12-months
time frame: Measured at baseline and at 12-months after the bariatric surgery
description: Serum levels of insulin. Units of gut hormones include insulin in ulu/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
measure: Changes in blood levels of leptin at 6-months
time frame: Measured at baseline and at 6-months after the bariatric surgery
description: Serum levels of leptin. Units of gut hormones include Leptin in ng/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
measure: Changes in blood levels of leptin at 12-months
time frame: Measured at baseline and at 12-months after the bariatric surgery
description: Serum levels of leptin. Units of gut hormones include Leptin in ng/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
measure: Changes in gut microbiome at 6 months
time frame: Measured at baseline and at 6-months after the bariatric surgery
description: High-Throughput Microbiome Sequencing for sequencing of the 16S ribosomal RNA. Output sequences are classified as domain, phylum, family and genus to species, depending on the depth of reliable classifier assignments ribosomal RNA (rRNA) gene as the genetic marker to study bacterial phylogeny and taxonomy.
measure: Changes in gut microbiome at 12 months
time frame: Measured at baseline and at 12-months after the bariatric surgery
description: High-Throughput Microbiome Sequencing for sequencing of the 16S ribosomal RNA. Output sequences are classified as domain, phylum, family and genus to species, depending on the depth of reliable classifier assignments ribosomal RNA (rRNA) gene as the genetic marker to study bacterial phylogeny and taxonomy.
measure: Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 6 months
time frame: Measured at baseline and at 6-months after the bariatric surgery
description: Functional brain images will be obtained using established acquisition protocols for resting state and evoked brain responses
measure: Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 12 months
time frame: Measured at baseline and at 12-months after the bariatric surgery
description: Functional brain images will be obtained using established acquisition protocols for resting state and evoked brain responses
measure: Changes in Inflammatory markers at 6 months
time frame: Measured at baseline and at 6-months after the bariatric surgery
description: Serum levels of adipokines and inflammatory cytokines. Units include: Adiponectin in pg/ml, Interleukin 1β in pg/ml , Interleukin 6 in pg/ml, Lipopolysaccharide in pg/ml, tumor-necrosis-factor TNF-α in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines
measure: Changes in Inflammatory markers at 12 months
time frame: Measured at baseline and at 12-months after the bariatric surgery
description: Serum levels of adipokines and inflammatory cytokines. Units include: Adiponectin in pg/ml, Interleukin 1β in pg/ml , Interleukin 6 in pg/ml, Lipopolysaccharide in pg/ml, tumor-necrosis-factor TNF-α in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines
measure: Changes in metabolite concentrations at 6 months.
time frame: Measured at baseline and at 6-months after the bariatric surgery
description: Differences in blood metabolite concentrations measured by mass spectrometry, comparing metabolite concentrations from obese patients at baseline and after bariatric surgery.
measure: Changes in metabolite concentrations at 12 months.
time frame: Measured at baseline and at 12-months after the bariatric surgery
description: Differences in blood metabolite concentrations measured by mass spectrometry, comparing metabolite concentrations from obese patients at baseline and after bariatric surgery.
intervention type: Procedure
intervention name: Bariatric surgery
description: Laparoscopic bariatric surgery including gastric bypass and sleeve gastrectomy
Stool samples for 16S RNA analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Weight Loss
sharing ipd: Undecided