<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/NCT03784508</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)320-2018</org_study_id>
    <nct_id>NCT03784508</nct_id>
  </id_info>
  <brief_title>Identification of Biomarkers of Response After Bariatric Surgery in Morbidly Obese Patients</brief_title>
  <acronym>PREDI-BAR</acronym>
  <official_title>Identification of Biomarkers of Response After Bariatric Surgery in Morbidly Obese Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</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>
      The prevalence of obesity in Spain is about 21.6%. The discouraging results provided by&#xD;
      dietary treatment, together with the lack of funding for pharmacological treatment, have led&#xD;
      to the progressive use of bariatric surgery (CB). Besides weight loss, CB associates a&#xD;
      beneficial effect on metabolic comorbidities. However, 25-30% of operated patients present a&#xD;
      weight response considered inappropriate, they do not resolve their comorbidities and/or&#xD;
      present a weight-regain shortly after surgery. Therefore, predictive strategies are necessary&#xD;
      to allow a correct selection of obese patients who are candidates for CB.&#xD;
&#xD;
      The main hypothesis of the study is that various factors such as psychopathological profile,&#xD;
      body composition and metabolic alterations related to morbid obesity can influence the&#xD;
      response to bariatric surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators have designed a prospective study in which 200 consecutive patients from&#xD;
      the outpatient clinic of the Morbidly Obesity Unit of the Vall d'Hebron Hospital will be&#xD;
      included, meeting criteria for bariatric surgery (with BMI&gt; 40 kg / m2 or BMI&gt; 35 kg /m2 in&#xD;
      the presence of comorbidities) and will undergo surgery in the investigator's center between&#xD;
      September 2018 and September 2019. All patients will undergo (baseline, month, 6, 12 and 24&#xD;
      month): complete clinical history, analysis complete biochemistry, 2 blood samples will be&#xD;
      extracted to study metabolomics, stool sample for microbiota study, bioimpedance for the&#xD;
      study of body composition, determination of AGEs in the skin and lens, cognitive function&#xD;
      assessment, retinal function assessment by microperimetry and they will be asked to complete&#xD;
      several specific questionnaires for the evaluation of the psychopathological profile and the&#xD;
      dietetic survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">April 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Evolution of the body mass index in morbidly obesity patients after bariatric surgery (BS).</measure>
    <time_frame>24month</time_frame>
    <description>For the assessment of the evolution after bariatric surgery the investigators will use the body mass index parameter (BMI), calculated with the following formula: Body mass index (BMI) will be calculated as weight (kg)/height (m2).&#xD;
Changes in BMI, will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evolution of the excess of weight loss % (EWL%) after bariatric surgery.</measure>
    <time_frame>24 month</time_frame>
    <description>- Excess of weight loss % (EWL%) will be calculated using the following formula: pre-bariatric surgery weight (kg)-visit weight (kg)/pre-bariatric surgery weight (kg)- ideal weight (for BMI 25) (kg) x 100%. Changes in EWL% will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evolution of the total weight loss after bariatric surgery</measure>
    <time_frame>24 month</time_frame>
    <description>-Total weight loss (TWL) will be calculated as: pre-bariatric surgery weight (kg)- visit weight (kg). Changes in TWL will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the body composition scores before and after bariatric surgery by means of bioimpedanciometry.</measure>
    <time_frame>24 month</time_frame>
    <description>All the patients will undergo before and after bariatric surgery (after 1,6, 12, and 24 month) the bioimpedance Bodystat QuadScan 4000 evaluation. The results are expressed in kg of free fatty mass and fatty mass. The change in Kg of the free fatty mass and fatty mass regarding the baseline will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the Advanced Glycation End products (AGEs) before and after bariatric surgery.</measure>
    <time_frame>24 month</time_frame>
    <description>All the patients will undergo AGEs evaluation before, at 6, 12, 24 months after bariatric surgery (eye and skin using CLEARPATH DS-120 and microCAYA-AGEreader respectively). The presence of the AGEs is automatically calculated as standard deviation from the normal values for age and gender. The differences between the baseline value, at 6,12 and 24 month will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neuropsychological scores before and after bariatric surgery: eating attitudes</measure>
    <time_frame>24month</time_frame>
    <description>Eating Attitudes Test (EAT) evaluates the possible eating disorders of the patients. The test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will search for correlations with the BMI, EWL% and TWL changes. The subjects will have to answer 40 items, each of it measured from 0 to 3, total score may range between 0 and 120. The accepted cut-off for diagnosis eating disorders is more than 20 for spanish population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neuropsychological scores before and after bariatric surgery: Attention-Deficit Hyperactivity Disorder (ADHD)</measure>
    <time_frame>24month</time_frame>
    <description>ADHD rating scale will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The scale ranges between 0-27 points, the highest the value, the higher de attention deficit and hyperactivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neuropsychological scores before and after bariatric surgery: Sheehan Disability Inventory (SDI).</measure>
    <time_frame>24 month</time_frame>
    <description>Sheehan Disability Inventory (SDI) scale will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The Sheehan Disability Inventory evaluates the social fobia and the score ranges between 0-30. A score &gt; 15 is considered pathological.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neuropsychological scores before and after bariatric surgery: Zuckerman-Kuhlman Personality Questionnaire (ZKPQ).</measure>
    <time_frame>24month</time_frame>
    <description>ZKPQ personality evaluation will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. ZKPQ is a quantitative scale which evaluates 6 personality dimensions: aggressivity (19 points), anxiety (19 points), impulsivity (17 points), activity (17 points), sociability (17 points). There is no clear cut-off for this test. In consequence, there will be evaluated only the changes after the bariatric surgery, compared with the baseline score. The higher the score the higher the personality disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neuropsychological scores before and after bariatric surgery: COPE- stress management strategies.</measure>
    <time_frame>24month</time_frame>
    <description>COPE test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. COPE is a quantitative scale which evaluates 15 strategies of stress coping. The total score ranges between 15-60 points. There is a direct relation between the score and the ability to manage the stress, but no clear cut-off for this test exists. In consequence, we will only evaluate the changes after the bariatric surgery regarding the baseline score. The highest score indicates better strategies to cope the stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neuropsychological scores before and after bariatric surgery: ROTTER´s locus of control scale.</measure>
    <time_frame>24month</time_frame>
    <description>ROTTER´s locus of control scale test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. COPE is a quantitative scale which a total score ranging between 0-29 points. The cut-off value &lt;15 defines the internal locus of control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neuropsychological scores before and after bariatric surgery: YALE food addiction.</measure>
    <time_frame>24month</time_frame>
    <description>YALE food addiction scale test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. There is a direct relation between the score and the food addiction, is a quantitative scale but there is no clear cut-off. There will be evaluated the changes in the score at 6,12, and 24 month after the bariatric surgery, comparing with baseline. The highest the score, the higher the food addiction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neuropsychological scores before and after bariatric surgery:The Bariatric Analysis and Reporting Outcome System (B.A.R.OS).</measure>
    <time_frame>24month</time_frame>
    <description>B.A.R.O.S test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. B.A.R.O.S. is a quantitative questionnaire evaluating the quality of life after the bariatric surgery. The scale ranges between 0 and 9. The higher the score the highest the quality of life of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neuropsychological scores before and after bariatric surgery: The State-Trait Anxiety Inventory (STAI).</measure>
    <time_frame>24month</time_frame>
    <description>STAI anxiety questionnaire evaluates the degree of the anxiety of the patient and will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The score ranges between 0 and 60. A cut-off value&gt; 19 is considered pathological anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neuropsychological scores before and after bariatric surgery: WPAI (working productivity questionnaire).</measure>
    <time_frame>24month</time_frame>
    <description>WPAI questionnaire will be used before, at 6, 12, and 24month after bariatric surgery and the results will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. There is a qualitative score, evaluating the working status of the patient: retiree, active, off-work&gt;6month, unemployed, permanent occupational disability. Percentages of each category will be evaluated at each time. Ej: % of unemployed, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neuropsychological scores before and after bariatric surgery: Beck Depression Inventory (BDI)</measure>
    <time_frame>24month</time_frame>
    <description>BDI evaluates if depression exists and its degree. It will be used before, at 6, 12, and 24month after bariatric surgery and the results will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The score ranges between 0-40. 0-10: normal; 10-16 mild emotional; 17-20: borderline clinical depression; 21-30 moderate depression; 31-40 severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the congnitive function before and after bariatric surgery</measure>
    <time_frame>24 month</time_frame>
    <description>Minimental State Evaluation Test and Montreal Cognitive Assessment test will be used before and at 12 and 24 month after bariatric surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the utility of the retinal function evaluation in the detection of cognitive disfunction before and after bariatric surgery</measure>
    <time_frame>24 month</time_frame>
    <description>Retinal microperimetry using MAIA 3rd generation microperimeter will be used before and at 12 and 24 month after the bariatric surgery</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>Bariatric surgery</arm_group_label>
    <description>200 consecutive patients that will undergo bariatric surgery as a routinary procedure at our site</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool samples Blood samples DNA from saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients that are attended at our outpatient clinic of the Morbid Obesity Unit&#xD;
        of Vall Hebron University Hospital, that will undergo BS between September 2018 and&#xD;
        December 2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients fulfilling criteria for bariatric surgery (BS).&#xD;
&#xD;
          -  Signed informed consent fir the BS and the study.&#xD;
&#xD;
          -  Previous accomplishment of the preoperative protocol for the BS at our site.&#xD;
&#xD;
          -  undergo BS between September 2018 and December 2019&#xD;
&#xD;
          -  Able to read and understand the specific questionnaires.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication for the bariatric surgery.&#xD;
&#xD;
          -  Impossibility to follow-up at our site (eg: patients from outside out community).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Andreea Ciudin, MD, PhD</last_name>
    <phone>697817352</phone>
    <email>aciudin@vhebron.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Andreea Ciudin</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreea Ciudin, MD, PhD</last_name>
      <phone>697817352</phone>
      <email>aciudin@vhebron.net</email>
    </contact>
    <contact_backup>
      <last_name>Diana Romero Godoy, Nurse</last_name>
      <email>diana.romero@vhir.org</email>
    </contact_backup>
    <investigator>
      <last_name>Diana Romero Godoy, Nurse</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Enzamaria Fidilio, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andreea Ciudin, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Angel Ortiz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marta Comas, Dietis</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marta Sanchez, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitari Vall d'Hebron Research Institute</investigator_affiliation>
    <investigator_full_name>Andreea Ciudin</investigator_full_name>
    <investigator_title>Head of the Morbid Obesity Unit and Clinical Trials Department</investigator_title>
  </responsible_party>
  <keyword>morbid obesity</keyword>
  <keyword>bariatric surgery</keyword>
  <keyword>psychological profile</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</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/NCT03784508
org study id: PR(AG)320-2018
nct id: NCT03784508
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prevalence of obesity in Spain is about 21.6%. The discouraging results provided by
      dietary treatment, together with the lack of funding for pharmacological treatment, have led
      to the progressive use of bariatric surgery (CB). Besides weight loss, CB associates a
      beneficial effect on metabolic comorbidities. However, 25-30% of operated patients present a
      weight response considered inappropriate, they do not resolve their comorbidities and/or
      present a weight-regain shortly after surgery. Therefore, predictive strategies are necessary
      to allow a correct selection of obese patients who are candidates for CB.

      The main hypothesis of the study is that various factors such as psychopathological profile,
      body composition and metabolic alterations related to morbid obesity can influence the
      response to bariatric surgery.
The investigators have designed a prospective study in which 200 consecutive patients from
      the outpatient clinic of the Morbidly Obesity Unit of the Vall d'Hebron Hospital will be
      included, meeting criteria for bariatric surgery (with BMI> 40 kg / m2 or BMI> 35 kg /m2 in
      the presence of comorbidities) and will undergo surgery in the investigator's center between
      September 2018 and September 2019. All patients will undergo (baseline, month, 6, 12 and 24
      month): complete clinical history, analysis complete biochemistry, 2 blood samples will be
      extracted to study metabolomics, stool sample for microbiota study, bioimpedance for the
      study of body composition, determination of AGEs in the skin and lens, cognitive function
      assessment, retinal function assessment by microperimetry and they will be asked to complete
      several specific questionnaires for the evaluation of the psychopathological profile and the
      dietetic survey.
observational model: Cohort
time perspective: Prospective
measure: Evolution of the body mass index in morbidly obesity patients after bariatric surgery (BS).
time frame: 24month
description: For the assessment of the evolution after bariatric surgery the investigators will use the body mass index parameter (BMI), calculated with the following formula: Body mass index (BMI) will be calculated as weight (kg)/height (m2).
Changes in BMI, will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.
measure: Evolution of the excess of weight loss % (EWL%) after bariatric surgery.
time frame: 24 month
description: - Excess of weight loss % (EWL%) will be calculated using the following formula: pre-bariatric surgery weight (kg)-visit weight (kg)/pre-bariatric surgery weight (kg)- ideal weight (for BMI 25) (kg) x 100%. Changes in EWL% will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.
measure: Evolution of the total weight loss after bariatric surgery
time frame: 24 month
description: -Total weight loss (TWL) will be calculated as: pre-bariatric surgery weight (kg)- visit weight (kg). Changes in TWL will be evaluated at 1, 6, 12 and 24 month after bariatric surgery.
measure: Evaluation of the body composition scores before and after bariatric surgery by means of bioimpedanciometry.
time frame: 24 month
description: All the patients will undergo before and after bariatric surgery (after 1,6, 12, and 24 month) the bioimpedance Bodystat QuadScan 4000 evaluation. The results are expressed in kg of free fatty mass and fatty mass. The change in Kg of the free fatty mass and fatty mass regarding the baseline will be evaluated.
measure: Evaluation of the Advanced Glycation End products (AGEs) before and after bariatric surgery.
time frame: 24 month
description: All the patients will undergo AGEs evaluation before, at 6, 12, 24 months after bariatric surgery (eye and skin using CLEARPATH DS-120 and microCAYA-AGEreader respectively). The presence of the AGEs is automatically calculated as standard deviation from the normal values for age and gender. The differences between the baseline value, at 6,12 and 24 month will be evaluated.
measure: Evaluation of neuropsychological scores before and after bariatric surgery: eating attitudes
time frame: 24month
description: Eating Attitudes Test (EAT) evaluates the possible eating disorders of the patients. The test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will search for correlations with the BMI, EWL% and TWL changes. The subjects will have to answer 40 items, each of it measured from 0 to 3, total score may range between 0 and 120. The accepted cut-off for diagnosis eating disorders is more than 20 for spanish population.
measure: Evaluation of neuropsychological scores before and after bariatric surgery: Attention-Deficit Hyperactivity Disorder (ADHD)
time frame: 24month
description: ADHD rating scale will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The scale ranges between 0-27 points, the highest the value, the higher de attention deficit and hyperactivity.
measure: Evaluation of neuropsychological scores before and after bariatric surgery: Sheehan Disability Inventory (SDI).
time frame: 24 month
description: Sheehan Disability Inventory (SDI) scale will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The Sheehan Disability Inventory evaluates the social fobia and the score ranges between 0-30. A score > 15 is considered pathological.
measure: Evaluation of neuropsychological scores before and after bariatric surgery: Zuckerman-Kuhlman Personality Questionnaire (ZKPQ).
time frame: 24month
description: ZKPQ personality evaluation will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. ZKPQ is a quantitative scale which evaluates 6 personality dimensions: aggressivity (19 points), anxiety (19 points), impulsivity (17 points), activity (17 points), sociability (17 points). There is no clear cut-off for this test. In consequence, there will be evaluated only the changes after the bariatric surgery, compared with the baseline score. The higher the score the higher the personality disorder.
measure: Evaluation of neuropsychological scores before and after bariatric surgery: COPE- stress management strategies.
time frame: 24month
description: COPE test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. COPE is a quantitative scale which evaluates 15 strategies of stress coping. The total score ranges between 15-60 points. There is a direct relation between the score and the ability to manage the stress, but no clear cut-off for this test exists. In consequence, we will only evaluate the changes after the bariatric surgery regarding the baseline score. The highest score indicates better strategies to cope the stress.
measure: Evaluation of neuropsychological scores before and after bariatric surgery: ROTTER´s locus of control scale.
time frame: 24month
description: ROTTER´s locus of control scale test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. COPE is a quantitative scale which a total score ranging between 0-29 points. The cut-off value <15 defines the internal locus of control.
measure: Evaluation of neuropsychological scores before and after bariatric surgery: YALE food addiction.
time frame: 24month
description: YALE food addiction scale test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. There is a direct relation between the score and the food addiction, is a quantitative scale but there is no clear cut-off. There will be evaluated the changes in the score at 6,12, and 24 month after the bariatric surgery, comparing with baseline. The highest the score, the higher the food addiction.
measure: Evaluation of neuropsychological scores before and after bariatric surgery:The Bariatric Analysis and Reporting Outcome System (B.A.R.OS).
time frame: 24month
description: B.A.R.O.S test will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. B.A.R.O.S. is a quantitative questionnaire evaluating the quality of life after the bariatric surgery. The scale ranges between 0 and 9. The higher the score the highest the quality of life of the patient.
measure: Evaluation of neuropsychological scores before and after bariatric surgery: The State-Trait Anxiety Inventory (STAI).
time frame: 24month
description: STAI anxiety questionnaire evaluates the degree of the anxiety of the patient and will be used before, at 6, 12, and 24month after bariatric surgery and the scores will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The score ranges between 0 and 60. A cut-off value> 19 is considered pathological anxiety.
measure: Evaluation of neuropsychological scores before and after bariatric surgery: WPAI (working productivity questionnaire).
time frame: 24month
description: WPAI questionnaire will be used before, at 6, 12, and 24month after bariatric surgery and the results will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. There is a qualitative score, evaluating the working status of the patient: retiree, active, off-work>6month, unemployed, permanent occupational disability. Percentages of each category will be evaluated at each time. Ej: % of unemployed, etc.
measure: Evaluation of neuropsychological scores before and after bariatric surgery: Beck Depression Inventory (BDI)
time frame: 24month
description: BDI evaluates if depression exists and its degree. It will be used before, at 6, 12, and 24month after bariatric surgery and the results will be compared. The investigators will evaluate the existence of correlations with the BMI, EWL% and TWL changes. The score ranges between 0-40. 0-10: normal; 10-16 mild emotional; 17-20: borderline clinical depression; 21-30 moderate depression; 31-40 severe depression.
measure: Evaluation of the congnitive function before and after bariatric surgery
time frame: 24 month
description: Minimental State Evaluation Test and Montreal Cognitive Assessment test will be used before and at 12 and 24 month after bariatric surgery
measure: Evaluation of the utility of the retinal function evaluation in the detection of cognitive disfunction before and after bariatric surgery
time frame: 24 month
description: Retinal microperimetry using MAIA 3rd generation microperimeter will be used before and at 12 and 24 month after the bariatric surgery
arm group label: Bariatric surgery
description: 200 consecutive patients that will undergo bariatric surgery as a routinary procedure at our site
Stool samples Blood samples DNA from saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andreea Ciudin, MD, PhD
phone: 697817352
email: aciudin@vhebron.net
facility: 
status: Recruiting
contact: 
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country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitari Vall d'Hebron Research Institute
investigator full name: Andreea Ciudin
investigator title: Head of the Morbid Obesity Unit and Clinical Trials Department
mesh term: Obesity, Morbid
sharing ipd: No