<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/NCT02994901</url>
  </required_header>
  <id_info>
    <org_study_id>EA1/260/16</org_study_id>
    <nct_id>NCT02994901</nct_id>
  </id_info>
  <brief_title>Cause and Importance of the Age-dependent Sarcopenia</brief_title>
  <acronym>SARCOPENIA</acronym>
  <official_title>Cause and Importance of the Age-dependent Sarcopenia With a Blood Based Bioenergetics &amp; Cytokine Profiling Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Institute of Human Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this cross-sectional study is to evaluate the difference in cytokine profiling&#xD;
      approach and mitochondrial function between geriatric sarcopenic patients (group 1) and&#xD;
      geriatric non-sarcopenic patients (group 2) and healthy (group 3) geriatric participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study participants (group 1&amp;2) are assessed during the hospital stay and age-matched controls&#xD;
      (group 3) will be recruited through Flyers.&#xD;
&#xD;
      The investigators aim to isolate and cryopreserve peripheral blood mononuclear cells (PBMCs)&#xD;
      from whole blood to perform functional assays on mitochondrial respiratory capacity and ROS.&#xD;
      Furthermore, the investigators will investigate the association between biomarkers and&#xD;
      frailty, quality of life, functional performance, fatigue and risk of depression.&#xD;
&#xD;
      The investigators hypothesize that this profiling approach will allow the evaluation of the&#xD;
      progression of age-dependent sarcopenia and uncover novel therapeutic targets.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">July 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in mitochondrial respiratory capacity of peripheral blood mononuclear cells (PBMCs) using Oxygraph-2k respirometry</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life (validated questionnaire)</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frailty Status according to Fried et.al. criteria</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional limitations (single validated questionnaire)</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Geriatric patient with Sarcopenia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Geriatric Patient without Sarcopenia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>healthy control group</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1: sarcopenic patient Group 2: non-sarcopenic patient Group 3: healthy control&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 60 and 85 years&#xD;
&#xD;
          -  Informed written consent&#xD;
&#xD;
          -  Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)&#xD;
&#xD;
          -  Life expectancy of &gt; 3 months according to treating doctor&#xD;
&#xD;
          -  without implanted Defibrillation&#xD;
&#xD;
          -  without acute Sepsis&#xD;
&#xD;
          -  without neurodegenerative diseases, especially amyotrophic lateral sclerosis (ALS) and&#xD;
             Huntington&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 60 years or &gt; 85 years&#xD;
&#xD;
          -  Lack of informed written consent&#xD;
&#xD;
          -  Low cognitive status according to Mini-Mental State Examination (MMSE &lt; 24 points)&#xD;
&#xD;
          -  Life expectancy of &lt; 3 months according to treating doctor&#xD;
&#xD;
          -  Implanted Defibrillation&#xD;
&#xD;
          -  Acute Sepsis&#xD;
&#xD;
          -  neurodegenerative diseases, especially amyotrophic lateral sclerosis (ALS) and&#xD;
             Huntington&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristina Norman, PD Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite Research Group on Geriatrics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charite University Medicine, Research Group on Geriatrics</name>
      <address>
        <city>Berlin</city>
        <zip>13347</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Marzetti E, Calvani R, Cesari M, Buford TW, Lorenzi M, Behnke BJ, Leeuwenburgh C. Mitochondrial dysfunction and sarcopenia of aging: from signaling pathways to clinical trials. Int J Biochem Cell Biol. 2013 Oct;45(10):2288-301. doi: 10.1016/j.biocel.2013.06.024. Epub 2013 Jul 8.</citation>
    <PMID>23845738</PMID>
  </reference>
  <reference>
    <citation>Leger B, Derave W, De Bock K, Hespel P, Russell AP. Human sarcopenia reveals an increase in SOCS-3 and myostatin and a reduced efficiency of Akt phosphorylation. Rejuvenation Res. 2008 Feb;11(1):163-175B. doi: 10.1089/rej.2007.0588.</citation>
    <PMID>18240972</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Kristina Norman</investigator_full_name>
    <investigator_title>PD Dr.</investigator_title>
  </responsible_party>
  <keyword>Sarcopenia</keyword>
  <keyword>Geriatrics</keyword>
  <keyword>Biomarker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</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/NCT02994901
org study id: EA1/260/16
nct id: NCT02994901
lead sponsor: 
collaborator: 
has dmc: No
The goal of this cross-sectional study is to evaluate the difference in cytokine profiling
      approach and mitochondrial function between geriatric sarcopenic patients (group 1) and
      geriatric non-sarcopenic patients (group 2) and healthy (group 3) geriatric participants.
Study participants (group 1&2) are assessed during the hospital stay and age-matched controls
      (group 3) will be recruited through Flyers.

      The investigators aim to isolate and cryopreserve peripheral blood mononuclear cells (PBMCs)
      from whole blood to perform functional assays on mitochondrial respiratory capacity and ROS.
      Furthermore, the investigators will investigate the association between biomarkers and
      frailty, quality of life, functional performance, fatigue and risk of depression.

      The investigators hypothesize that this profiling approach will allow the evaluation of the
      progression of age-dependent sarcopenia and uncover novel therapeutic targets.
observational model: Cohort
time perspective: Cross-Sectional
measure: Differences in mitochondrial respiratory capacity of peripheral blood mononuclear cells (PBMCs) using Oxygraph-2k respirometry
time frame: Baseline
measure: Quality of life (validated questionnaire)
time frame: Baseline
measure: Frailty Status according to Fried et.al. criteria
time frame: Baseline
measure: Functional limitations (single validated questionnaire)
time frame: Baseline
arm group label: Group 1
description: Geriatric patient with Sarcopenia
arm group label: Group 2
description: Geriatric Patient without Sarcopenia
arm group label: Group 3
description: healthy control group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kristina Norman, PD Dr.
role: Principal Investigator
affiliation: Charite Research Group on Geriatrics
facility: 
country: Germany
citation: Marzetti E, Calvani R, Cesari M, Buford TW, Lorenzi M, Behnke BJ, Leeuwenburgh C. Mitochondrial dysfunction and sarcopenia of aging: from signaling pathways to clinical trials. Int J Biochem Cell Biol. 2013 Oct;45(10):2288-301. doi: 10.1016/j.biocel.2013.06.024. Epub 2013 Jul 8.
PMID: 23845738
citation: Leger B, Derave W, De Bock K, Hespel P, Russell AP. Human sarcopenia reveals an increase in SOCS-3 and myostatin and a reduced efficiency of Akt phosphorylation. Rejuvenation Res. 2008 Feb;11(1):163-175B. doi: 10.1089/rej.2007.0588.
PMID: 18240972
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Kristina Norman
investigator title: PD Dr.
mesh term: Sarcopenia
sharing ipd: No