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/NCT05961878</url>
    </required_header>
    <id_info>
      <org_study_id>Sarcopenia-diabetes</org_study_id>
      <nct_id>NCT05961878</nct_id>
    </id_info>
    <brief_title>Diet in Elderly With Type 2 Diabetes</brief_title>
    <acronym>SARC-OLD</acronym>
    <official_title>Efficacy of Diet in Elderly With Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</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>
        Sarcopenia is characterized by progressive and generalized loss of skeletal muscle mass which&#xD;
        may affect performance. Diabetes can affect muscle cell function, making sarcopenia worse.&#xD;
  &#xD;
        This is a prospective and interventional study on a elderly population affected by type 2&#xD;
        diabetes mellitus. All subjects, recruited will undergo tests for the diagnosis of sarcopenia&#xD;
        according to the EWGSOP2 criteria. All subjects, both sarcopenic and non-sarcopenic, will be&#xD;
        introduced to a targeted nutritional program aimed at improving the composition of the diet,&#xD;
        in terms of both micro- and macro-nutrients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The sample will consist of about 100 subjects (50 sarcopenic and 50 non-sarcopenic) who&#xD;
        receive the nutritional program. Particular attention will be paid to the intake of an&#xD;
        adequate protein intake for the elderly subject (1.1 g/kg/day). A food diary will be required&#xD;
        to assess daily protein-calorie intake and questionnaires to assess daily physical activity&#xD;
        and quality of life.&#xD;
  &#xD;
        The primary objective is to assess the efficacy of nutritional intervention in elderly&#xD;
        affected by type 2 diabetes mellitus and sarcopenia. The secondary objective is to identify&#xD;
        the prevalence of sarcopenia in patients with type 2 diabetes mellitus compared to&#xD;
        non-diabetic subjects and to verify the relationship between pharmacological therapy and the&#xD;
        presence of sarcopenia as well as evaluate any changes in style and quality of life and of&#xD;
        glycometabolic compensation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 31, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Handgrip test</measure>
      <time_frame>1 years</time_frame>
      <description>Increase of hand grip strength (units: kg)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Glycemic control</measure>
      <time_frame>1 year</time_frame>
      <description>HbA1c (units: mmol/mol)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS</measure>
      <time_frame>1 year</time_frame>
      <description>fat mass and free fat mass (units: % of total mass)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary lifestyle</measure>
      <time_frame>1 year</time_frame>
      <description>variations in intake of simple sugars, animal protein rich foods, saturated fats and cholesterol, UDM: grams/die. All the informations will be collected using 5days food diaries, completed by the patients</description>
    </secondary_outcome>
    <other_outcome>
      <measure>health-related quality of life</measure>
      <time_frame>1 year</time_frame>
      <description>assesed Sacopenia Quality of life (SarQoL)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Sarcopenia</condition>
    <condition>Sarcopenic Obesity</condition>
    <condition>Diabetes Mellitus</condition>
    <condition>Diabetes Mellitus, Type 2</condition>
    <condition>Diabetes Complications</condition>
    <arm_group>
      <arm_group_label>Sarcopenic</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>subjects with sarcopenia diagnosis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non sarcopenic</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>subjects without sarcopenia diagnosis</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>mediterranean diet with adequate protein intake</intervention_name>
      <description>balanced mediterranean diet with 1.1 g/kg die protein intake</description>
      <arm_group_label>Non sarcopenic</arm_group_label>
      <arm_group_label>Sarcopenic</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Type 2 Diabetes&#xD;
  &#xD;
            -  BMI &gt;20 kg/m2&#xD;
  &#xD;
            -  HbA1c ≥6.5% (48 mmol/mol) e ≤10% (86 mmol/mol)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  T1DM or LADA&#xD;
  &#xD;
            -  Patients with serious primary diseases of heart, brain, liver, kidney and&#xD;
               hematopoietic system&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Alessia Gaglio, biologist</last_name>
      <phone>00393408724498</phone>
      <email>alessia.gaglio91@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emanuela Orsi, MD</last_name>
      <phone>00390255033498</phone>
      <email>emanuela_orsi@yahoo.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
        <address>
          <city>Milan</city>
          <zip>20122</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</investigator_affiliation>
      <investigator_full_name>Emanuela Orsi</investigator_full_name>
      <investigator_title>medical doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sarcopenia</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
      <mesh_term>Diabetes Complications</mesh_term>
    </condition_browse>
    <!-- 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/NCT05961878
  org study id: Sarcopenia-diabetes
  nct id: NCT05961878
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Sarcopenia is characterized by progressive and generalized loss of skeletal muscle mass which
        may affect performance. Diabetes can affect muscle cell function, making sarcopenia worse.
  
        This is a prospective and interventional study on a elderly population affected by type 2
        diabetes mellitus. All subjects, recruited will undergo tests for the diagnosis of sarcopenia
        according to the EWGSOP2 criteria. All subjects, both sarcopenic and non-sarcopenic, will be
        introduced to a targeted nutritional program aimed at improving the composition of the diet,
        in terms of both micro- and macro-nutrients.
  The sample will consist of about 100 subjects (50 sarcopenic and 50 non-sarcopenic) who
        receive the nutritional program. Particular attention will be paid to the intake of an
        adequate protein intake for the elderly subject (1.1 g/kg/day). A food diary will be required
        to assess daily protein-calorie intake and questionnaires to assess daily physical activity
        and quality of life.
  
        The primary objective is to assess the efficacy of nutritional intervention in elderly
        affected by type 2 diabetes mellitus and sarcopenia. The secondary objective is to identify
        the prevalence of sarcopenia in patients with type 2 diabetes mellitus compared to
        non-diabetic subjects and to verify the relationship between pharmacological therapy and the
        presence of sarcopenia as well as evaluate any changes in style and quality of life and of
        glycometabolic compensation.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Handgrip test
  time frame: 1 years
  description: Increase of hand grip strength (units: kg)
  measure: Glycemic control
  time frame: 1 year
  description: HbA1c (units: mmol/mol)
  measure: Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS
  time frame: 1 year
  description: fat mass and free fat mass (units: % of total mass)
  measure: Dietary lifestyle
  time frame: 1 year
  description: variations in intake of simple sugars, animal protein rich foods, saturated fats and cholesterol, UDM: grams/die. All the informations will be collected using 5days food diaries, completed by the patients
  measure: health-related quality of life
  time frame: 1 year
  description: assesed Sacopenia Quality of life (SarQoL)
  arm group label: Sarcopenic
  arm group type: Experimental
  description: subjects with sarcopenia diagnosis
  arm group label: Non sarcopenic
  arm group type: Placebo Comparator
  description: subjects without sarcopenia diagnosis
  intervention type: Dietary Supplement
  intervention name: mediterranean diet with adequate protein intake
  description: balanced mediterranean diet with 1.1 g/kg die protein intake
  arm group label: Non sarcopenic
  arm group label: Sarcopenic
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 95 Years
  healthy volunteers: No
  last name: Alessia Gaglio, biologist
  phone: 00393408724498
  email: alessia.gaglio91@gmail.com
  last name: Emanuela Orsi, MD
  phone: 00390255033498
  email: emanuela_orsi@yahoo.it
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  investigator full name: Emanuela Orsi
  investigator title: medical doctor
  mesh term: Sarcopenia
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Diabetes Complications