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/NCT05997251</url>
    </required_header>
    <id_info>
      <org_study_id>E2-21-89</org_study_id>
      <nct_id>NCT05997251</nct_id>
    </id_info>
    <brief_title>The Relationship of DASH and Mediterranean Diet Score With Serum Adiponectin Levels in Patients With Spinal Cord Injury</brief_title>
    <official_title>The Relationship of DASH and Mediterranean Diet Score With Serum Adiponectin Levels in Patients With Spinal Cord Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara City Hospital Bilkent</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara City Hospital Bilkent</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to reveal the relationship of DASH and Mediterranean diet score with&#xD;
        anthropometric measurements and serum adiponectin level in individuals with spinal cord&#xD;
        injury. This research was planned as a cross-sectional, case-control study. With the data to&#xD;
        be obtained from the research, information will be obtained about the hormonal or biochemical&#xD;
        basis of metabolic disorders such as atherosclerosis and insulin resistance that may occur in&#xD;
        individuals with spinal cord injury in the long term.&#xD;
  &#xD;
        20 individuals with Spinal Cord Injury will be included in the study, and the results of the&#xD;
        patients will be compared with 20 healthy individuals. In order to determine the food&#xD;
        consumption status of the patients, a 1-day food consumption record will be requested. DASH&#xD;
        diet score and Mediterranean diet score will be calculated from dietary records. After 8&#xD;
        hours of fasting, 3 ml of peripheral blood will be taken for the measurement of adiponectin&#xD;
        between 08:00 and 09:00 in the morning from the individuals in the study and control groups.&#xD;
        Adiponectin level will be measured and its correlation with DASH diet score and Mediterranean&#xD;
        diet score will be examined.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2021</start_date>
    <completion_date type="Actual">March 1, 2022</completion_date>
    <primary_completion_date type="Actual">March 1, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Adiponectin level</measure>
      <time_frame>Will be measured at inclusion</time_frame>
      <description>Adiponectin level will be measured from peripheral blood</description>
    </primary_outcome>
    <primary_outcome>
      <measure>DASH diet score</measure>
      <time_frame>Will be measured at inclusion from one day dietary record</time_frame>
      <description>Will be measured at inclusion from one day dietary record</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mediterrenian diet score</measure>
      <time_frame>Will be measured at inclusion from one day dietary record</time_frame>
      <description>Will be measured at inclusion from one day dietary record</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Whole blood count</measure>
      <time_frame>Will be measured at inclusion</time_frame>
      <description>Will be measured at inclusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fasting blood glucose</measure>
      <time_frame>Will be measured at inclusion</time_frame>
      <description>Will be measured at inclusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total cholesterol</measure>
      <time_frame>Will be measured at inclusion</time_frame>
      <description>Will be measured at inclusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LDL</measure>
      <time_frame>Will be measured at inclusion</time_frame>
      <description>Will be measured at inclusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HDL</measure>
      <time_frame>Will be measured at inclusion</time_frame>
      <description>Will be measured at inclusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TG</measure>
      <time_frame>Will be measured at inclusion</time_frame>
      <description>Will be measured at inclusion</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">66</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <arm_group>
      <arm_group_label>Patients with spinal cord injury</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy group</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Keeping a 1-day food consumption record by the patient</intervention_name>
      <description>Checking and receiving the 1-day food consumption record recorded by the patient by the researcher</description>
      <arm_group_label>Healthy group</arm_group_label>
      <arm_group_label>Patients with spinal cord injury</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Measurement of adiponectin level</intervention_name>
      <description>Adiponectin level will be measured for each group</description>
      <arm_group_label>Healthy group</arm_group_label>
      <arm_group_label>Patients with spinal cord injury</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients admitted to hospital Healthy population from patient care givers of hospital staff&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion criteria (Study group)&#xD;
  &#xD;
                 -  Having spent at least 6 months after spinal cord injury&#xD;
  &#xD;
                 -  1st motor neuron injury&#xD;
  &#xD;
                 -  Being between the ages of 18-65&#xD;
  &#xD;
                 -  Giving consent to participate in the study Inclusion criteria (Control group)&#xD;
  &#xD;
                 -  Being between the ages of 18-65&#xD;
  &#xD;
                 -  Giving consent to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exclusion criteria (Study group)&#xD;
  &#xD;
                 -  Having an additional disease to the spinal cord injury&#xD;
  &#xD;
                 -  Having a 2nd motor neuron lesion&#xD;
  &#xD;
          Exclusion criteria (Control group)&#xD;
  &#xD;
          • Having any disease&#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>
    <location>
      <facility>
        <name>Ankara Bilkent City Hospital Physical Treatment and Rehabilitation Hospital</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Wang YH, Huang TS, Liang HW, Su TC, Chen SY, Wang TD. Fasting serum levels of adiponectin, ghrelin, and leptin in men with spinal cord injury. Arch Phys Med Rehabil. 2005 Oct;86(10):1964-8. doi: 10.1016/j.apmr.2005.04.017. Erratum In: Arch Phys Med Rehabil. 2007 May;88(5):688.</citation>
      <PMID>16213239</PMID>
    </reference>
    <reference>
      <citation>Ekmekci H, Ekmekci OB. The role of adiponectin in atherosclerosis and thrombosis. Clin Appl Thromb Hemost. 2006 Apr;12(2):163-8. doi: 10.1177/107602960601200203.</citation>
      <PMID>16708117</PMID>
    </reference>
    <reference>
      <citation>O'Brien LC, Graham ZA, Chen Q, Lesnefsky EJ, Cardozo C, Gorgey AS. Plasma adiponectin levels are correlated with body composition, metabolic profiles, and mitochondrial markers in individuals with chronic spinal cord injury. Spinal Cord. 2018 Sep;56(9):863-872. doi: 10.1038/s41393-018-0089-8. Epub 2018 Mar 20.</citation>
      <PMID>29559683</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara City Hospital Bilkent</investigator_affiliation>
      <investigator_full_name>Emre Adıgüzel</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>Adiponectin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05997251
  org study id: E2-21-89
  nct id: NCT05997251
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to reveal the relationship of DASH and Mediterranean diet score with
        anthropometric measurements and serum adiponectin level in individuals with spinal cord
        injury. This research was planned as a cross-sectional, case-control study. With the data to
        be obtained from the research, information will be obtained about the hormonal or biochemical
        basis of metabolic disorders such as atherosclerosis and insulin resistance that may occur in
        individuals with spinal cord injury in the long term.
  
        20 individuals with Spinal Cord Injury will be included in the study, and the results of the
        patients will be compared with 20 healthy individuals. In order to determine the food
        consumption status of the patients, a 1-day food consumption record will be requested. DASH
        diet score and Mediterranean diet score will be calculated from dietary records. After 8
        hours of fasting, 3 ml of peripheral blood will be taken for the measurement of adiponectin
        between 08:00 and 09:00 in the morning from the individuals in the study and control groups.
        Adiponectin level will be measured and its correlation with DASH diet score and Mediterranean
        diet score will be examined.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Adiponectin level
  time frame: Will be measured at inclusion
  description: Adiponectin level will be measured from peripheral blood
  measure: DASH diet score
  time frame: Will be measured at inclusion from one day dietary record
  description: Will be measured at inclusion from one day dietary record
  measure: Mediterrenian diet score
  time frame: Will be measured at inclusion from one day dietary record
  description: Will be measured at inclusion from one day dietary record
  measure: Whole blood count
  time frame: Will be measured at inclusion
  description: Will be measured at inclusion
  measure: Fasting blood glucose
  time frame: Will be measured at inclusion
  description: Will be measured at inclusion
  measure: Total cholesterol
  time frame: Will be measured at inclusion
  description: Will be measured at inclusion
  measure: LDL
  time frame: Will be measured at inclusion
  description: Will be measured at inclusion
  measure: HDL
  time frame: Will be measured at inclusion
  description: Will be measured at inclusion
  measure: TG
  time frame: Will be measured at inclusion
  description: Will be measured at inclusion
  arm group label: Patients with spinal cord injury
  arm group label: Healthy group
  intervention type: Other
  intervention name: Keeping a 1-day food consumption record by the patient
  description: Checking and receiving the 1-day food consumption record recorded by the patient by the researcher
  arm group label: Healthy group
  arm group label: Patients with spinal cord injury
  intervention type: Other
  intervention name: Measurement of adiponectin level
  description: Adiponectin level will be measured for each group
  arm group label: Healthy group
  arm group label: Patients with spinal cord injury
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  citation: Wang YH, Huang TS, Liang HW, Su TC, Chen SY, Wang TD. Fasting serum levels of adiponectin, ghrelin, and leptin in men with spinal cord injury. Arch Phys Med Rehabil. 2005 Oct;86(10):1964-8. doi: 10.1016/j.apmr.2005.04.017. Erratum In: Arch Phys Med Rehabil. 2007 May;88(5):688.
  PMID: 16213239
  citation: Ekmekci H, Ekmekci OB. The role of adiponectin in atherosclerosis and thrombosis. Clin Appl Thromb Hemost. 2006 Apr;12(2):163-8. doi: 10.1177/107602960601200203.
  PMID: 16708117
  citation: O'Brien LC, Graham ZA, Chen Q, Lesnefsky EJ, Cardozo C, Gorgey AS. Plasma adiponectin levels are correlated with body composition, metabolic profiles, and mitochondrial markers in individuals with chronic spinal cord injury. Spinal Cord. 2018 Sep;56(9):863-872. doi: 10.1038/s41393-018-0089-8. Epub 2018 Mar 20.
  PMID: 29559683
  responsible party type: Principal Investigator
  investigator affiliation: Ankara City Hospital Bilkent
  investigator full name: Emre Adıgüzel
  investigator title: MD
  mesh term: Spinal Cord Injuries
  mesh term: Wounds and Injuries
  sharing ipd: No