<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/NCT03249259</url>
  </required_header>
  <id_info>
    <org_study_id>B-1508-312-006</org_study_id>
    <nct_id>NCT03249259</nct_id>
  </id_info>
  <brief_title>The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes</brief_title>
  <official_title>The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</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>
      In this study, the investigators are going to investigate the efficacy of choline alfoscerate&#xD;
      on improvement of cognitive function assessed by MMSE compared to plaebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will enroll patients with type 2 diabetes whose age is equal to higher than&#xD;
      60, and randomly assigned study drug or placebo at 1:1 ratio. The treatment duration is 6&#xD;
      months and extension study will be continued to 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2016</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>double blind placebo controlled study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>6 months</time_frame>
    <description>Change of MMSE Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose metabolism</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose metabolism</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in fasting glucose concentration</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hypoglycemia</measure>
    <time_frame>6 months</time_frame>
    <description>Incidence of hypoglycemia</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Choline alfoscerate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>choline alfoscerate 400mg (2 caps - 1 cap bid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (2 caps - 1 cap bid)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Choline alfoscerate</intervention_name>
    <description>Treatment duration is 6 months and can be extended to 12 months with participant's agreement.</description>
    <arm_group_label>Choline alfoscerate</arm_group_label>
    <other_name>Choline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Treatment duration is 6 months and can be extended to 12 months with participant's agreement.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  type 2 diabetes&#xD;
&#xD;
          -  baseline MMSE score 25-28&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  type 1 diabetes&#xD;
&#xD;
          -  diabetes ketoacidosis or hyperosmolar hyperglycemic crisis&#xD;
&#xD;
          -  HbA1c over than 9.0%&#xD;
&#xD;
          -  MMSE less than 25&#xD;
&#xD;
          -  abnormal TSH levels&#xD;
&#xD;
          -  vitamin B12 deficiency&#xD;
&#xD;
          -  severe infection, perioperative state, trauma&#xD;
&#xD;
          -  hypopituitarism or adrenal insufficiency&#xD;
&#xD;
          -  any conditions that lead to hospitalization&#xD;
&#xD;
          -  chronic alcoholics within 1 year&#xD;
&#xD;
          -  any drugs that can influence to cognitive function within 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>October 4, 2019</last_update_submitted>
  <last_update_submitted_qc>October 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Soo Lim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choline</mesh_term>
  </intervention_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/NCT03249259
org study id: B-1508-312-006
nct id: NCT03249259
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators are going to investigate the efficacy of choline alfoscerate
      on improvement of cognitive function assessed by MMSE compared to plaebo.
The investigators will enroll patients with type 2 diabetes whose age is equal to higher than
      60, and randomly assigned study drug or placebo at 1:1 ratio. The treatment duration is 6
      months and extension study will be continued to 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: double blind placebo controlled study.
measure: Cognitive function
time frame: 6 months
description: Change of MMSE Score
measure: Glucose metabolism
time frame: 6 months
description: Changes in HbA1c
measure: Glucose metabolism
time frame: 6 months
description: Changes in fasting glucose concentration
measure: Hypoglycemia
time frame: 6 months
description: Incidence of hypoglycemia
arm group label: Choline alfoscerate
arm group type: Experimental
description: choline alfoscerate 400mg (2 caps - 1 cap bid)
arm group label: Control
arm group type: Placebo Comparator
description: Placebo (2 caps - 1 cap bid)
intervention type: Drug
intervention name: Choline alfoscerate
description: Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
arm group label: Choline alfoscerate
other name: Choline
intervention type: Drug
intervention name: Placebo
description: Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
arm group label: Control
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Soo Lim
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Choline
sharing ipd: No