xml: <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/NCT05987631</url>
    </required_header>
    <id_info>
      <org_study_id>2021_136</org_study_id>
      <secondary_id>NL77692.018.21</secondary_id>
      <secondary_id>NTR9447</secondary_id>
      <nct_id>NCT05987631</nct_id>
    </id_info>
    <brief_title>Predictors of Weight Loss and Metabolic Health After Bariatric Surgery</brief_title>
    <official_title>Preoperative Predictors of Weight Loss and Improved Metabolic Health After Bariatric Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Obesitas Kliniek B.V.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Radboud University Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
    <oversight_info>
      <has_dmc>Yes</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>
        In this prospective study the investigators aim to identify preoperative predictors of&#xD;
        improvement of metabolic health and weight loss after bariatric surgery focusing on&#xD;
        inflammation, insulin sensitivity (in a subgroup of patients), glucoregulatory determinants,&#xD;
        psychological traits, feeding behavior characteristics and cardiorespiratory fitness&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Obesity is the result of a complex interplay between genetic and epigenetic predisposition,&#xD;
        environment, physical activity, nutrition and psychology. It is a debilitating disorder and a&#xD;
        risk factor for the development of metabolic disorders such as dyslipidaemia, hypertension&#xD;
        and hyperglycaemia as well as certain cancers. Bariatric surgery has proven to be the most&#xD;
        effective treatment for morbid obesity with established long-term results of weight loss,&#xD;
        remission of comorbid conditions and the improvement of Quality of Life (QoL). However,&#xD;
        variability in these results after bariatric surgery is well known. Identifying preoperative&#xD;
        predictors of postoperative weight loss and metabolic health is of clinical priority.&#xD;
        Predictors could help further improve the efficacy of care for obesity by tailoring treatment&#xD;
        to the individual, based on their predicted response and therefore optimize outcome after&#xD;
        bariatric surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 19, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Predictors of improvement in metabolic health - insulin sensitivity</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>HOMA-IR</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Predictors of improvement in metabolic health - level of glucose control</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>HbA1C (mmol/mol)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Predictors of improvement in metabolic health - glucose</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Fasting glucose (mmol/L)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Predictors of improvement in metabolic health - insulin</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Insulin (pmol/L)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Predictors of improvement in metabolic health - lipid profile</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Lipids (mmol/L)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Predictors of improvement in metabolic health - biomarker inflammation</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>CRP (mg/L)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Predictors of improvement in metabolic health</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Genetic variants using GWAS analysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Predictors of weight loss</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Genetic variants using GWAS analysis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Psychological factors - depression</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Patient-Reported Outcomes Measurement Information System Depression (PROMIS-D: validated questionnaire for bariatric surgery. PROMIS-D: range in score from 8 to 40, higher scores indicating greater severity of depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological factors - anxiety</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Patient-Reported Outcomes Measurement Information System Anxiety (PROMIS-A): validated questionnaire for bariatric surgery. PROMIS-A: range in score from 7 to 35, higher scores indicating greater severity of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological factors - impulsivity</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Measurements of impulsiveness Barret Impulsiveness Scale (BIS): validated questionnaire to assess level of impulsivity&#xD;
  BIS-11: The total scores can range from 30 to 120. Higher scores on the BIS reflect higher levels of impulsiveness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological factors - impulsivity</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Measurements of impulsiveness Iowa Gambling Task: validated task to study impulsive behaviour&#xD;
  Iowa gambling task: The net score is calculated by subtracting the number of disadvantageous selections from the advantageous selections. A positive net score indicates better performance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Predictors of weight loss - food addiction</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Food addiction scale (YFAS 2.0): validated questionnaire to assess food addiction.&#xD;
  YFAS 2.0 includes two scoring methods, a continuous symptom count and a diagnosis of food addiction.&#xD;
  Continious symptom count ranges from zero to eleven, Diagnosis of food addiction: no food addiction (0-1 symptoms), a mild food addicition (2-3 symptoms), a moderate food addiction (4-5 symptoms), or a severe food addiction (&gt;6 symptoms).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Predictors of weight loss - eating behaviour</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Dutch Eating Behaviour Questionnaire (DEBQ): validated questionnaire to assess eating behaviour.&#xD;
  DEBQ consists of 33 items.Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Predictors of weight loss - Quality of Life</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Selfesteem scale of Impact of Weight on Quality of Life - lite (IWQOL-lite): validated questionnaire after weight loss interventions. The self-esteem scale consists of 7 items. Each item is rated on a 5-point scale. Higher scores represent better quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Predictors of weight loss - Quality of Life</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>OBESI-Q (Obesity): validated questionnaire for reporting Health Related Quality of Life. Outcome is expressed on a 100 point scale, a higher score is higher quality of life, with the exception of item &quot;Excess skin&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Predictors of weight loss - Quality of Life</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>EuroQuality of Life (EQ-5D): validated questionnaire for reporting Quality of Life after bariatric surgery. Each item is rated on a 5-point scale. Higher scores represent lower reported quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Predictors of weight loss - Impulsivity</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Measurements of impulsiveness Barret Impulsiveness Scale (BIS): validated questionnaire to assess level of impulsivity&#xD;
  BIS-11: The total scores can range from 30 to 120. Higher scores on the BIS reflect higher levels of impulsiveness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Predictors of weight loss - Impulsivity</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Measurements of impulsiveness Iowa Gambling Task: validated task to study impulsive behaviour&#xD;
  Iowa gambling task: The net score is calculated by subtracting the number of disadvantageous selections from the advantageous selections. A positive net score indicates better performance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Predictors of weight loss - Physical activity</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Short Questionnaire to Assess Health Enhancing Physical Activity (SQUASH): validated questionnaire to assess physical activity.&#xD;
  The SQUASH measures the frequency, duration and intensity of 5 different physical activities: commuting (traveling to and from work/study), housekeeping , activities at work, leisure time, and sports. A higher score = more time spend on physical activities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sexual dimorphism in weight loss</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Males versus females regarding weight loss (kg) and percentage of total weight loss</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sexual dimorphism in restoration of metabolic health - insulin sensitivity</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Males versus females regarding insulin sensitivity (HOMA-IR) and measurements of glucose and insuline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sexual dimorphism in restoration of metabolic health - improvement of diabetes</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Males versus females regarding HbA1c values and diabetic drug use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sexual dimorphism in restoration of metabolic health - lipid</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Males versus females regarding lipids (mmol/L) and lipid-lowering agents use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sexual dimorphism in restoration of metabolic health - hypertension</measure>
      <time_frame>Baseline up to 5 years after surgery</time_frame>
      <description>Males versus females regarding blood pressure (mmHg) and anithypertensive medication use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peripheral insulin sensitivity</measure>
      <time_frame>Before and 3 and 18 months after bariatric surgery</time_frame>
      <description>In a subset of 40 patients insulin sensitivity will be assessed using hyperinsulinemic euglycemic clamps, and adipose tissue and skeletal muscle biopsies will be taken to assess insulin signalling (expression of mRNA and phosphorylated proteins)</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1200</enrollment>
    <condition>Obesity, Morbid</condition>
    <condition>Insulin Sensitivity</condition>
    <condition>Bariatric Surgery Candidate</condition>
    <condition>Feeding Behavior</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Plasma, serum and tissue (fat, muscle, liver)&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients of the Nederlandse Obesitas Kliniek (Dutch Obesity Clinic).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to provide informed consent&#xD;
  &#xD;
            -  Patient is ≥ 18 and ≤ 75 years old&#xD;
  &#xD;
            -  BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with obesity related comorbidity&#xD;
  &#xD;
            -  Scheduled for primary bariatric procedure: Roux-en-Y gastric bypass (RYGB) or Sleeve&#xD;
               Gastrectomy (SG)&#xD;
  &#xD;
            -  Stable weight 3 months prior to inclusion weight (&lt;10% change in body weight for 3&#xD;
               months prior to assessments)&#xD;
  &#xD;
          In order to be eligible to participate in the subgroup of this study, we will use the&#xD;
          following inclusion criteria:&#xD;
  &#xD;
            -  Ability to provide informed consent&#xD;
  &#xD;
            -  Patient is ≥ 18 and ≤ 75 years old&#xD;
  &#xD;
            -  BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with obesity related comorbidity&#xD;
  &#xD;
            -  Patients scheduled for RYGB&#xD;
  &#xD;
            -  Patients who are insulin resistant (impaired fasting glucose (&gt; 5.6 mmol/L) or fasting&#xD;
               insulin &gt; 74 pmol/L)&#xD;
  &#xD;
            -  Postmenopausal women (to prevent bias due to the effect of sex hormones on insulin&#xD;
               sensitivity)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any actual medical condition except for obesity related health issues or well treated&#xD;
               hypothyroidism&#xD;
  &#xD;
            -  Pregnancy anticipated in the first two years following surgery&#xD;
  &#xD;
          A potential subject who meet the following criteria will be excluded from participation in&#xD;
          the subgroup of this study:&#xD;
  &#xD;
            -  Coagulation disorders and/or use anticoagulants&#xD;
  &#xD;
            -  Use of any medication except for statins, antihypertensives (except for Angiotensine&#xD;
               converting enzyme (ACE)- or angiotensin receptor blockers) and thyroid hormone&#xD;
  &#xD;
            -  Diabetes mellitus type 2&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mireille JM Serlie, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Valerie M Monpellier, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Obesitas Nederland B.V.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rieneke van der Meer, Drs.</last_name>
      <phone>+31703204703</phone>
      <email>r.vandermeer1@amsterdamumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lianda CH Luiijpers, Drs.</last_name>
      <email>lianda.luijpers@radboudumc.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nederlandse Obesitas Kliniek Nieuwegein</name>
        <address>
          <city>Nieuwegein</city>
          <state>Utrecht</state>
          <zip>3431HK</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Lianda Luijpers, Drs.</last_name>
        <email>lianda.luijpers@radboudumc.nl</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nederlandse Obesitas Kliniek Den Haag</name>
        <address>
          <city>Den Haag</city>
          <state>Zuid-Holland</state>
          <zip>2591XR</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rieneke van der Meer, Drs.</last_name>
        <phone>+31703204703</phone>
        <email>rvandermeer@obesitaskliniek.nl</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nederlandse Obesitas Kliniek Gouda</name>
        <address>
          <city>Gouda</city>
          <state>Zuid-Holland</state>
          <zip>2803PW</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Rieneke van der Meer, Drs.</last_name>
        <phone>+31182232040</phone>
        <email>rvandermeer@obesitaskliniek.nl</email>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Prof. Dr. Mireille JM Serlie</investigator_full_name>
      <investigator_title>Prof. Dr. Mireille JM Serlie</investigator_title>
    </responsible_party>
    <keyword>Obesity</keyword>
    <keyword>Bariatric Surgery</keyword>
    <keyword>Metabolic health</keyword>
    <keyword>Weight loss</keyword>
    <keyword>Predictors</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Insulin Resistance</mesh_term>
      <mesh_term>Obesity, Morbid</mesh_term>
      <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>
  
  
text: 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/NCT05987631
  org study id: 2021_136
  secondary id: NL77692.018.21
  secondary id: NTR9447
  nct id: NCT05987631
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  In this prospective study the investigators aim to identify preoperative predictors of
        improvement of metabolic health and weight loss after bariatric surgery focusing on
        inflammation, insulin sensitivity (in a subgroup of patients), glucoregulatory determinants,
        psychological traits, feeding behavior characteristics and cardiorespiratory fitness
  Obesity is the result of a complex interplay between genetic and epigenetic predisposition,
        environment, physical activity, nutrition and psychology. It is a debilitating disorder and a
        risk factor for the development of metabolic disorders such as dyslipidaemia, hypertension
        and hyperglycaemia as well as certain cancers. Bariatric surgery has proven to be the most
        effective treatment for morbid obesity with established long-term results of weight loss,
        remission of comorbid conditions and the improvement of Quality of Life (QoL). However,
        variability in these results after bariatric surgery is well known. Identifying preoperative
        predictors of postoperative weight loss and metabolic health is of clinical priority.
        Predictors could help further improve the efficacy of care for obesity by tailoring treatment
        to the individual, based on their predicted response and therefore optimize outcome after
        bariatric surgery.
  observational model: Cohort
  time perspective: Prospective
  measure: Predictors of improvement in metabolic health - insulin sensitivity
  time frame: Baseline up to 5 years after surgery
  description: HOMA-IR
  measure: Predictors of improvement in metabolic health - level of glucose control
  time frame: Baseline up to 5 years after surgery
  description: HbA1C (mmol/mol)
  measure: Predictors of improvement in metabolic health - glucose
  time frame: Baseline up to 5 years after surgery
  description: Fasting glucose (mmol/L)
  measure: Predictors of improvement in metabolic health - insulin
  time frame: Baseline up to 5 years after surgery
  description: Insulin (pmol/L)
  measure: Predictors of improvement in metabolic health - lipid profile
  time frame: Baseline up to 5 years after surgery
  description: Lipids (mmol/L)
  measure: Predictors of improvement in metabolic health - biomarker inflammation
  time frame: Baseline up to 5 years after surgery
  description: CRP (mg/L)
  measure: Predictors of improvement in metabolic health
  time frame: Baseline up to 5 years after surgery
  description: Genetic variants using GWAS analysis
  measure: Predictors of weight loss
  time frame: Baseline up to 5 years after surgery
  description: Genetic variants using GWAS analysis
  measure: Psychological factors - depression
  time frame: Baseline up to 5 years after surgery
  description: Patient-Reported Outcomes Measurement Information System Depression (PROMIS-D: validated questionnaire for bariatric surgery. PROMIS-D: range in score from 8 to 40, higher scores indicating greater severity of depression
  measure: Psychological factors - anxiety
  time frame: Baseline up to 5 years after surgery
  description: Patient-Reported Outcomes Measurement Information System Anxiety (PROMIS-A): validated questionnaire for bariatric surgery. PROMIS-A: range in score from 7 to 35, higher scores indicating greater severity of anxiety.
  measure: Psychological factors - impulsivity
  time frame: Baseline up to 5 years after surgery
  description: Measurements of impulsiveness Barret Impulsiveness Scale (BIS): validated questionnaire to assess level of impulsivity
  BIS-11: The total scores can range from 30 to 120. Higher scores on the BIS reflect higher levels of impulsiveness.
  measure: Psychological factors - impulsivity
  time frame: Baseline up to 5 years after surgery
  description: Measurements of impulsiveness Iowa Gambling Task: validated task to study impulsive behaviour
  Iowa gambling task: The net score is calculated by subtracting the number of disadvantageous selections from the advantageous selections. A positive net score indicates better performance
  measure: Predictors of weight loss - food addiction
  time frame: Baseline up to 5 years after surgery
  description: Food addiction scale (YFAS 2.0): validated questionnaire to assess food addiction.
  YFAS 2.0 includes two scoring methods, a continuous symptom count and a diagnosis of food addiction.
  Continious symptom count ranges from zero to eleven, Diagnosis of food addiction: no food addiction (0-1 symptoms), a mild food addicition (2-3 symptoms), a moderate food addiction (4-5 symptoms), or a severe food addiction (>6 symptoms).
  measure: Predictors of weight loss - eating behaviour
  time frame: Baseline up to 5 years after surgery
  description: Dutch Eating Behaviour Questionnaire (DEBQ): validated questionnaire to assess eating behaviour.
  DEBQ consists of 33 items.Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.
  measure: Predictors of weight loss - Quality of Life
  time frame: Baseline up to 5 years after surgery
  description: Selfesteem scale of Impact of Weight on Quality of Life - lite (IWQOL-lite): validated questionnaire after weight loss interventions. The self-esteem scale consists of 7 items. Each item is rated on a 5-point scale. Higher scores represent better quality of life.
  measure: Predictors of weight loss - Quality of Life
  time frame: Baseline up to 5 years after surgery
  description: OBESI-Q (Obesity): validated questionnaire for reporting Health Related Quality of Life. Outcome is expressed on a 100 point scale, a higher score is higher quality of life, with the exception of item "Excess skin".
  measure: Predictors of weight loss - Quality of Life
  time frame: Baseline up to 5 years after surgery
  description: EuroQuality of Life (EQ-5D): validated questionnaire for reporting Quality of Life after bariatric surgery. Each item is rated on a 5-point scale. Higher scores represent lower reported quality of life.
  measure: Predictors of weight loss - Impulsivity
  time frame: Baseline up to 5 years after surgery
  description: Measurements of impulsiveness Barret Impulsiveness Scale (BIS): validated questionnaire to assess level of impulsivity
  BIS-11: The total scores can range from 30 to 120. Higher scores on the BIS reflect higher levels of impulsiveness.
  measure: Predictors of weight loss - Impulsivity
  time frame: Baseline up to 5 years after surgery
  description: Measurements of impulsiveness Iowa Gambling Task: validated task to study impulsive behaviour
  Iowa gambling task: The net score is calculated by subtracting the number of disadvantageous selections from the advantageous selections. A positive net score indicates better performance
  measure: Predictors of weight loss - Physical activity
  time frame: Baseline up to 5 years after surgery
  description: Short Questionnaire to Assess Health Enhancing Physical Activity (SQUASH): validated questionnaire to assess physical activity.
  The SQUASH measures the frequency, duration and intensity of 5 different physical activities: commuting (traveling to and from work/study), housekeeping , activities at work, leisure time, and sports. A higher score = more time spend on physical activities.
  measure: Sexual dimorphism in weight loss
  time frame: Baseline up to 5 years after surgery
  description: Males versus females regarding weight loss (kg) and percentage of total weight loss
  measure: Sexual dimorphism in restoration of metabolic health - insulin sensitivity
  time frame: Baseline up to 5 years after surgery
  description: Males versus females regarding insulin sensitivity (HOMA-IR) and measurements of glucose and insuline
  measure: Sexual dimorphism in restoration of metabolic health - improvement of diabetes
  time frame: Baseline up to 5 years after surgery
  description: Males versus females regarding HbA1c values and diabetic drug use
  measure: Sexual dimorphism in restoration of metabolic health - lipid
  time frame: Baseline up to 5 years after surgery
  description: Males versus females regarding lipids (mmol/L) and lipid-lowering agents use
  measure: Sexual dimorphism in restoration of metabolic health - hypertension
  time frame: Baseline up to 5 years after surgery
  description: Males versus females regarding blood pressure (mmHg) and anithypertensive medication use
  measure: Peripheral insulin sensitivity
  time frame: Before and 3 and 18 months after bariatric surgery
  description: In a subset of 40 patients insulin sensitivity will be assessed using hyperinsulinemic euglycemic clamps, and adipose tissue and skeletal muscle biopsies will be taken to assess insulin signalling (expression of mRNA and phosphorylated proteins)
  Plasma, serum and tissue (fat, muscle, liver)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Mireille JM Serlie, Prof. Dr.
  role: Principal Investigator
  affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  last name: Valerie M Monpellier, Dr.
  role: Principal Investigator
  affiliation: Obesitas Nederland B.V.
  last name: Rieneke van der Meer, Drs.
  phone: +31703204703
  email: r.vandermeer1@amsterdamumc.nl
  last name: Lianda CH Luiijpers, Drs.
  email: lianda.luijpers@radboudumc.nl
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Prof. Dr. Mireille JM Serlie
  investigator title: Prof. Dr. Mireille JM Serlie
  mesh term: Insulin Resistance
  mesh term: Obesity, Morbid
  mesh term: Weight Loss
  sharing ipd: Undecided