<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/NCT03008525</url>
  </required_header>
  <id_info>
    <org_study_id>2016-23</org_study_id>
    <nct_id>NCT03008525</nct_id>
  </id_info>
  <brief_title>Vitamin D and Its Metabolites Quantification in Adipose Tissues of Obese and Non-obese Patients.</brief_title>
  <acronym>VITADOSE</acronym>
  <official_title>Vitamin D and Its Metabolites Quantification in Adipose Tissues of Obese and Non-obese</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      Vitamin D (VD) is a pleiotropic hormone, involved in many physiological processes including&#xD;
      calcium and phosphorus absorption. The VD metabolism begin to be well-known and involves a&#xD;
      hepatic hydroxylation (mediated by enzymes, which belong to the cytochrome P450 family)&#xD;
      leading to the production of the 25(OH)D, which corresponds to the circulating form of the&#xD;
      VD. After circulation in blood, the 25(OH)D is submitted to a second hydroxylation in the&#xD;
      kidney resulting to the generation of 1,25(OH)2D, the active metabolite of VD. Numerous&#xD;
      epidemiological studies reported an inverse relationship between obesity and circulation&#xD;
      level of 25(OH)D. Several mechanisms could explain the low level of 25(OH)D observed in obese&#xD;
      subjects, the more classical evoked being based on sequestration and/or dilution of VD in&#xD;
      adipose tissue (AT), the main VD storage site. However, this mechanism has never been&#xD;
      demonstrated. In order to confirm this hypothesis, the concentration of VD and its&#xD;
      metabolites in adipose tissue need to be quantified.&#xD;
&#xD;
      The objective of this study is to determine the concentration of VD and its metabolites in&#xD;
      adipose tissue as well as adipose tissue mass quantification and distribution (visceral or&#xD;
      subcutaneous) to highlight putative difference of VD and its metabolites quantities between&#xD;
      obese and non-obese patients. A quantification of VD metabolism, inflammation and lipid&#xD;
      metabolism gene expression will be realized on biopsies. Correlations between gene expression&#xD;
      and quantity of VD in tissue will be carrying out.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 17, 2017</start_date>
  <completion_date type="Anticipated">September 13, 2026</completion_date>
  <primary_completion_date type="Anticipated">September 13, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>quantification of VD and its metabolites on subcutaneous and visceral adipose tissue biopsies</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Obesity; Endocrine</condition>
  <arm_group>
    <arm_group_label>obese patients (group OB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with body mass index ≥ 35 kg/m²</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-obese patients (group NO)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with body mass index &lt; 30 kg/m²</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>subcutaneous and visceral adipose tissue biopsies</intervention_name>
    <description>Subcutaneous and visceral adipose tissue biopsies during operation</description>
    <arm_group_label>non-obese patients (group NO)</arm_group_label>
    <arm_group_label>obese patients (group OB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>blood samples analysis</intervention_name>
    <description>Blood sampling is required to measure plasma cholecalciferol, calcidiol and calcitriol concentrations, as well as biological parameters of interest.&#xD;
Another plasma/serum tube is used to measure pro- and anti-inflammatory cytokines and adiponectin.</description>
    <arm_group_label>non-obese patients (group NO)</arm_group_label>
    <arm_group_label>obese patients (group OB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject with a BMI greater than 35 kg / m2 (group OB) or less than 30 kg / m² (group&#xD;
             NO)&#xD;
&#xD;
          -  Subject undergoing bariatric surgery (OB group) or abdominal surgery (group NO)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular intake of dietary supplements or vitamin supplements in the last three months&#xD;
&#xD;
          -  For the subjects of the group NO:&#xD;
&#xD;
               -  Malnourished patient (BMI &lt;18.5 kg / m2, weight loss greater than 5% in 1 month&#xD;
                  or 10% in 6 months)&#xD;
&#xD;
               -  Subject with an infection or inflammatory syndrome (CRP&gt; 10 mg / L and / or white&#xD;
                  blood cells&gt; 12000 / mm3)&#xD;
&#xD;
               -  Non-cancerous subject&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urielle Desalbres</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rene VALERO</last_name>
    <phone>0491383393</phone>
    <phone_ext>33</phone_ext>
    <email>rene.valero@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rene VALERO</last_name>
      <email>rene.valero@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03008525
org study id: 2016-23
nct id: NCT03008525
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vitamin D (VD) is a pleiotropic hormone, involved in many physiological processes including
      calcium and phosphorus absorption. The VD metabolism begin to be well-known and involves a
      hepatic hydroxylation (mediated by enzymes, which belong to the cytochrome P450 family)
      leading to the production of the 25(OH)D, which corresponds to the circulating form of the
      VD. After circulation in blood, the 25(OH)D is submitted to a second hydroxylation in the
      kidney resulting to the generation of 1,25(OH)2D, the active metabolite of VD. Numerous
      epidemiological studies reported an inverse relationship between obesity and circulation
      level of 25(OH)D. Several mechanisms could explain the low level of 25(OH)D observed in obese
      subjects, the more classical evoked being based on sequestration and/or dilution of VD in
      adipose tissue (AT), the main VD storage site. However, this mechanism has never been
      demonstrated. In order to confirm this hypothesis, the concentration of VD and its
      metabolites in adipose tissue need to be quantified.

      The objective of this study is to determine the concentration of VD and its metabolites in
      adipose tissue as well as adipose tissue mass quantification and distribution (visceral or
      subcutaneous) to highlight putative difference of VD and its metabolites quantities between
      obese and non-obese patients. A quantification of VD metabolism, inflammation and lipid
      metabolism gene expression will be realized on biopsies. Correlations between gene expression
      and quantity of VD in tissue will be carrying out.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: quantification of VD and its metabolites on subcutaneous and visceral adipose tissue biopsies
time frame: 12 months
arm group label: obese patients (group OB)
arm group type: Experimental
description: patients with body mass index ≥ 35 kg/m²
arm group label: non-obese patients (group NO)
arm group type: Active Comparator
description: patients with body mass index < 30 kg/m²
intervention type: Biological
intervention name: subcutaneous and visceral adipose tissue biopsies
description: Subcutaneous and visceral adipose tissue biopsies during operation
arm group label: non-obese patients (group NO)
arm group label: obese patients (group OB)
intervention type: Biological
intervention name: blood samples analysis
description: Blood sampling is required to measure plasma cholecalciferol, calcidiol and calcitriol concentrations, as well as biological parameters of interest.
Another plasma/serum tube is used to measure pro- and anti-inflammatory cytokines and adiponectin.
arm group label: non-obese patients (group NO)
arm group label: obese patients (group OB)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Urielle Desalbres
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Rene VALERO
phone: 0491383393
phone ext: 33
email: rene.valero@ap-hm.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor