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/NCT06007157</url>
    </required_header>
    <id_info>
      <org_study_id>SALT</org_study_id>
      <nct_id>NCT06007157</nct_id>
    </id_info>
    <brief_title>Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes</brief_title>
    <acronym>SALT</acronym>
    <official_title>Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Azienda Ospedaliero, Universitaria Pisana</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>European Foundation for the Study of Diabetes</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Azienda Ospedaliero, Universitaria Pisana</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 goal of this interventional study is to test whether sodium-glucose cotransporter 2&#xD;
        inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2&#xD;
        diabetes.&#xD;
  &#xD;
        Participants will undergo a dietary intervention consisting of a week of high-sodium diet,&#xD;
        followed by a week of low-sodium diet. At the end of each week the patients will undergo:&#xD;
  &#xD;
          -  24-h ambulatory blood pressure measurement;&#xD;
  &#xD;
          -  24-h urine collection;&#xD;
  &#xD;
          -  bioimpedance analysis for body composition determination;&#xD;
  &#xD;
          -  blood and urine tests.&#xD;
  &#xD;
        The study will compare patients treated with SGLT2i and patients not treated with SGLT2i to&#xD;
        test whether the treatment reduces the effects of high sodium intake on blood pressure, body&#xD;
        composition and biochemical variables.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>24-hour Blood Pressure</measure>
      <time_frame>2 weeks</time_frame>
      <description>Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sodium excretion</measure>
      <time_frame>2 weeks</time_frame>
      <description>24-hour sodium excretion will be measured by urine collection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hydration state</measure>
      <time_frame>2 weeks</time_frame>
      <description>Hydration state with extra- and intracellular water estimation will be measured by bioimpedance</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Blood Pressure</condition>
    <condition>Salt; Excess</condition>
    <condition>Diabete Type 2</condition>
    <arm_group>
      <arm_group_label>SGLT2i-treated patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Non SGLT2i-treated patients</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Hypersodic/Hyposodic diet</intervention_name>
      <description>Participants will undergo a dietary intervention consisting of a week of high-sodium diet (4800 mg/day), followed by a week of low-sodium diet (1200 mg/day).</description>
      <arm_group_label>Non SGLT2i-treated patients</arm_group_label>
      <arm_group_label>SGLT2i-treated patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age 18-65 years;&#xD;
  &#xD;
            -  both males and females;&#xD;
  &#xD;
            -  type 2 diabetes.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  type 1 diabetes;&#xD;
  &#xD;
            -  insulin treatment;&#xD;
  &#xD;
            -  uncontrolled hypertension (SBP &gt; 160 mmHg and/or DBP &gt;95 mmHg);&#xD;
  &#xD;
            -  pregnancy;&#xD;
  &#xD;
            -  other acute or chronic conditions influencing blood pressure and glucose metabolism.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andrea Natali</last_name>
      <role>Principal Investigator</role>
      <affiliation>Azienda Ospedaliero, Universitaria Pisana</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andrea Natali</last_name>
      <phone>+050992814</phone>
      <email>andrea.natali@unipi.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Martina Chiriacò</last_name>
      <phone>+050993640</phone>
      <email>martina.chiriaco@spec-med.unipi.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Azienda Ospedaliero-Universitaria Pisana</name>
        <address>
          <city>Pisa</city>
          <state>PI</state>
          <zip>56127</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrea Natali, MD</last_name>
        <phone>+39050992814</phone>
        <email>andrea.natali@med.unipi.it</email>
      </contact>
      <investigator>
        <last_name>Andrea Natali, Professor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Azienda Ospedaliero, Universitaria Pisana</investigator_affiliation>
      <investigator_full_name>Andrea Natali</investigator_full_name>
      <investigator_title>Full Professor of Nutrition</investigator_title>
    </responsible_party>
    <keyword>Salt sensitivity</keyword>
    <keyword>Sodium glucose cotransporter 2 inhibitors</keyword>
    <keyword>Type 2 Diabetes</keyword>
    <keyword>Blood Pressure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD will be shared with other researchers only upon reasonable request to the PI</ipd_description>
    </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/NCT06007157
  org study id: SALT
  nct id: NCT06007157
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this interventional study is to test whether sodium-glucose cotransporter 2
        inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2
        diabetes.
  
        Participants will undergo a dietary intervention consisting of a week of high-sodium diet,
        followed by a week of low-sodium diet. At the end of each week the patients will undergo:
  
          -  24-h ambulatory blood pressure measurement;
  
          -  24-h urine collection;
  
          -  bioimpedance analysis for body composition determination;
  
          -  blood and urine tests.
  
        The study will compare patients treated with SGLT2i and patients not treated with SGLT2i to
        test whether the treatment reduces the effects of high sodium intake on blood pressure, body
        composition and biochemical variables.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: 24-hour Blood Pressure
  time frame: 2 weeks
  description: Systolic and diastolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring
  measure: Sodium excretion
  time frame: 2 weeks
  description: 24-hour sodium excretion will be measured by urine collection
  measure: Hydration state
  time frame: 2 weeks
  description: Hydration state with extra- and intracellular water estimation will be measured by bioimpedance
  arm group label: SGLT2i-treated patients
  arm group type: Experimental
  arm group label: Non SGLT2i-treated patients
  arm group type: Active Comparator
  intervention type: Behavioral
  intervention name: Hypersodic/Hyposodic diet
  description: Participants will undergo a dietary intervention consisting of a week of high-sodium diet (4800 mg/day), followed by a week of low-sodium diet (1200 mg/day).
  arm group label: Non SGLT2i-treated patients
  arm group label: SGLT2i-treated patients
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Andrea Natali
  role: Principal Investigator
  affiliation: Azienda Ospedaliero, Universitaria Pisana
  last name: Andrea Natali
  phone: +050992814
  email: andrea.natali@unipi.it
  last name: Martina Chiriacò
  phone: +050993640
  email: martina.chiriaco@spec-med.unipi.it
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Azienda Ospedaliero, Universitaria Pisana
  investigator full name: Andrea Natali
  investigator title: Full Professor of Nutrition
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Hypersensitivity
  sharing ipd: No
  ipd description: IPD will be shared with other researchers only upon reasonable request to the PI