<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/NCT04407819</url>
  </required_header>
  <id_info>
    <org_study_id>EAPDionyssiotis</org_study_id>
    <nct_id>NCT04407819</nct_id>
  </id_info>
  <brief_title>Sarcopenia and Diabetes Mellitus</brief_title>
  <acronym>SARCoDM</acronym>
  <official_title>Sarcopenia and Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dionyssiotis, Yannis, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dionyssiotis, Yannis, M.D.</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>
      The association of diabetes mellitus type 2 (T2DM) with sarcopenia has not been adequately&#xD;
      investigated. Sarcopenia is characterized by progressive and generalized loss of skeletal&#xD;
      muscle mass which may affect performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The relationship between DM and sarcopenia has not been extensively investigated. Skeletal&#xD;
      muscle is the primary site of glucose deposition, and decreased muscle mass plays a role in&#xD;
      impaired glucose metabolism in patients with insulin resistance and type 2 diabetes. Skeletal&#xD;
      muscle resistance to insulin action appears to be the link between type 2 diabetes (T2DM) and&#xD;
      sarcopenia. Hyperglycemia is a metabolic dysfunction which can potentially damage muscle&#xD;
      cells. Insulin deficiency leads to marked muscle catabolism that can be reversed by exogenous&#xD;
      insulin administration.&#xD;
&#xD;
      The metabolic disorder in diabetics may be reversible.Thus, it may be possible to restore&#xD;
      physical ability by restoring the musculoskeletal system.Therefore, the diagnosis of&#xD;
      sarcopenia if made can lead to interventions which may prevent the deterioration of body&#xD;
      composition and the subsequent deterioration of quality of life. According to the results of&#xD;
      the aforementioned studies it is still inconclusive if the metabolic disorder in diabetes may&#xD;
      be related to sarcopenia, or sarcopenia may be a consequence of diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2018</start_date>
  <completion_date type="Actual">September 22, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Skeletal Muscle Index</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Appendicular Muscle Mass/Height2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>prevalence of sarcopenia in patients with T2D and in the control group</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>percents in different groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fat mass</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>percent of fat mass, Total Fat index</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>diabetes mellitus type 2</arm_group_label>
    <description>36 patients with diabetes mellitus type 2, aged 20-80 years, attending endocrinology outpatient clinics were studied for the assessment of muscle mass and function compared to controls.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROLS</arm_group_label>
    <description>14 community people who visited the endocrinology outpatient hospital clinic for a routine checkup, or with a non-related to diabetes disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>WHOLE BODY DXA</intervention_name>
    <description>Muscle mass was estimated by using the whole body DXA (Hologic Horizon W)</description>
    <arm_group_label>CONTROLS</arm_group_label>
    <arm_group_label>diabetes mellitus type 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A group of 36 patients, aged 20-80 years old, 18 male and 17 female with type 2 diabetes&#xD;
        mellitus, and a control group with the same demographic characteristics, participated in&#xD;
        the study. All were previously examined by an endocrinologist (in a public hospital,&#xD;
        private or university outpatient clinic) from March to July 2018. The control group&#xD;
        consisted of 14 community people who visited the endocrinology outpatient hospital clinic&#xD;
        for a routine checkup, or with a non-related to diabetes disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  T2DM participants were on treatment with oral hypoglycemic agents&#xD;
&#xD;
          -  confirmation criteria of a T2DM diagnosis were glycosylated hemoglobin A1c levels ≥&#xD;
             6.5% and fasting plasma glucose ≥ 126 mg/dl (7 mmol/l).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of a cerebrovascular event, a heart stent, an artificial cardiac pacemaker or&#xD;
             other metallic implant,&#xD;
&#xD;
          -  a malignant tumor, liver disease, end stage chronic kidney disease, a thyroid&#xD;
             disorder, carpal tunnel syndrome,&#xD;
&#xD;
          -  subjects who received special dietary supplements such as protein powder, during the&#xD;
             last three months were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yannis Dionyssiotis, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Foundation for Care of Neurological Illnesses, Greece</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foundation for Care of Neurological Illnesses, Greece</name>
      <address>
        <city>Athens</city>
        <state>Attica</state>
        <zip>11256</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Dionyssiotis Y. Sarcopenia in the Elderly. Eur Endocrinol. 2019 Apr;15(1):13-14. doi: 10.17925/EE.2019.15.1.13. Epub 2019 Apr 12.</citation>
    <PMID>31244904</PMID>
  </reference>
  <reference>
    <citation>Dionyssiotis Y, Kapsokoulou A, Samlidi E, Angoules AG, Papathanasiou J, Chronopoulos E, Kostoglou-Athanassiou I, Trovas G. Sarcopenia: From definition to treatment. Hormones (Athens). 2017 Oct;16(4):429-439. doi: 10.14310/horm.2002.1764. No abstract available.</citation>
    <PMID>29518764</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dionyssiotis, Yannis, M.D.</investigator_affiliation>
    <investigator_full_name>Yannis Dionyssiotis</investigator_full_name>
    <investigator_title>Post graduate student in Hellenic Open University of Greece</investigator_title>
  </responsible_party>
  <keyword>sarcopenia</keyword>
  <keyword>diabetes mellitus</keyword>
  <keyword>skeletal muscle index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04407819
org study id: EAPDionyssiotis
nct id: NCT04407819
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The association of diabetes mellitus type 2 (T2DM) with sarcopenia has not been adequately
      investigated. Sarcopenia is characterized by progressive and generalized loss of skeletal
      muscle mass which may affect performance.
The relationship between DM and sarcopenia has not been extensively investigated. Skeletal
      muscle is the primary site of glucose deposition, and decreased muscle mass plays a role in
      impaired glucose metabolism in patients with insulin resistance and type 2 diabetes. Skeletal
      muscle resistance to insulin action appears to be the link between type 2 diabetes (T2DM) and
      sarcopenia. Hyperglycemia is a metabolic dysfunction which can potentially damage muscle
      cells. Insulin deficiency leads to marked muscle catabolism that can be reversed by exogenous
      insulin administration.

      The metabolic disorder in diabetics may be reversible.Thus, it may be possible to restore
      physical ability by restoring the musculoskeletal system.Therefore, the diagnosis of
      sarcopenia if made can lead to interventions which may prevent the deterioration of body
      composition and the subsequent deterioration of quality of life. According to the results of
      the aforementioned studies it is still inconclusive if the metabolic disorder in diabetes may
      be related to sarcopenia, or sarcopenia may be a consequence of diabetes.
observational model: Case-Control
time perspective: Retrospective
measure: Skeletal Muscle Index
time frame: Up to 12 weeks
description: Appendicular Muscle Mass/Height2
measure: prevalence of sarcopenia in patients with T2D and in the control group
time frame: Up to 12 weeks
description: percents in different groups
measure: fat mass
time frame: Up to 12 weeks
description: percent of fat mass, Total Fat index
arm group label: diabetes mellitus type 2
description: 36 patients with diabetes mellitus type 2, aged 20-80 years, attending endocrinology outpatient clinics were studied for the assessment of muscle mass and function compared to controls.
arm group label: CONTROLS
description: 14 community people who visited the endocrinology outpatient hospital clinic for a routine checkup, or with a non-related to diabetes disease.
intervention type: Radiation
intervention name: WHOLE BODY DXA
description: Muscle mass was estimated by using the whole body DXA (Hologic Horizon W)
arm group label: CONTROLS
arm group label: diabetes mellitus type 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yannis Dionyssiotis, MD, PhD
role: Principal Investigator
affiliation: Foundation for Care of Neurological Illnesses, Greece
facility: 
country: Greece
citation: Dionyssiotis Y. Sarcopenia in the Elderly. Eur Endocrinol. 2019 Apr;15(1):13-14. doi: 10.17925/EE.2019.15.1.13. Epub 2019 Apr 12.
PMID: 31244904
citation: Dionyssiotis Y, Kapsokoulou A, Samlidi E, Angoules AG, Papathanasiou J, Chronopoulos E, Kostoglou-Athanassiou I, Trovas G. Sarcopenia: From definition to treatment. Hormones (Athens). 2017 Oct;16(4):429-439. doi: 10.14310/horm.2002.1764. No abstract available.
PMID: 29518764
responsible party type: Principal Investigator
investigator affiliation: Dionyssiotis, Yannis, M.D.
investigator full name: Yannis Dionyssiotis
investigator title: Post graduate student in Hellenic Open University of Greece
mesh term: Sarcopenia
mesh term: Diabetes Mellitus
sharing ipd: Undecided