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/NCT05998772</url>
    </required_header>
    <id_info>
      <org_study_id>D 537/23</org_study_id>
      <nct_id>NCT05998772</nct_id>
    </id_info>
    <brief_title>Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease</brief_title>
    <acronym>PaGlu</acronym>
    <official_title>Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Schleswig-Holstein</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Kiel</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital Schleswig-Holstein</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>
        Many patients with Parkinson's Disease (PD) report an increased consumption of fast-acting&#xD;
        sugars. This tendency to consume sweet, high-sugar foods occurs in some patients even before&#xD;
        the onset of cardinal motor symptoms. Some recent studies have demonstrated that PD patients&#xD;
        have an increased consumption of fast-acting carbohydrates compared to healthy controls.&#xD;
        However, the reason for this change in eating behavior has not yet been adequately explained.&#xD;
        It is discussed that the increased sugar intake leads to an increased dopamine release in the&#xD;
        brain via an increase in insulin and thus to an improvement in clinical symptoms. This study&#xD;
        investigates the influence of fast-acting carbohydrates on insulin and glucose blood levels&#xD;
        as well as motor and non-motor symptoms in patients with PD using an oral glucose tolerance&#xD;
        test and a placebo oral glucose tolerance test in a crossover design.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Concentration of Insulin in µU/mL</measure>
      <time_frame>immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application</time_frame>
      <description>Blood value</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Motor function</measure>
      <time_frame>immediately before Application of oral glucose tolerance test and placebo as well as 30, 60 and 120 minutes after application</time_frame>
      <description>assessed by Unified Parkinson's Disease Rating Scale Part III, 0-132 points, higher points indicate worse motor function</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Concentration of Blood Glucose in mg/dL</measure>
      <time_frame>immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application</time_frame>
      <description>Blood value</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cognitive function</measure>
      <time_frame>immediately before Application of oral glucose tolerance test and placebo as well as 60 minutes after application</time_frame>
      <description>assessed by Montreal-Cognitive-Assessment-Test (MoCa), 0-30 points, higher points indicate better cognitive function</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Parkinson Disease</condition>
    <condition>Nutritional and Metabolic Diseases</condition>
    <condition>Sugar Intake</condition>
    <arm_group>
      <arm_group_label>PD patients with craving for sweets</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>PD patients without craving for sweets</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Oral Glucose Tolerance Test</intervention_name>
      <description>Application of 82,5 g of glucose monohydrate solved in 300ml water</description>
      <arm_group_label>PD patients with craving for sweets</arm_group_label>
      <arm_group_label>PD patients without craving for sweets</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo Oral Glucose Tolerance Test</intervention_name>
      <description>Application of 125mg sucralose solved in 300ml water</description>
      <arm_group_label>PD patients with craving for sweets</arm_group_label>
      <arm_group_label>PD patients without craving for sweets</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population includes Parkinson's Disease patients with and without sweet cravings.&#xD;
          Recruitment of patients takes place in the outpatient clinic for movement disorders at the&#xD;
          University of Kiel.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of Parkinson's Disease, stage Hoehn &amp; Yahr 1.5-3&#xD;
  &#xD;
            -  Ability to pause antiparkinsonian medication in the morning without relevant&#xD;
               impairment&#xD;
  &#xD;
            -  Capacity to give consent (determined in doubt by two independent neurologists, MOCA&#xD;
               ≥18) and written informed consent.&#xD;
  &#xD;
            -  Patients are between 50 and 80 years of age, with exceptions for a maximum of 5&#xD;
               additional patients enrolled per group&#xD;
  &#xD;
            -  For stratification into patients with and without sweet craving, a 3-day dietary&#xD;
               protocol should be completed once by the patients&#xD;
  &#xD;
            -  Group I: increased hunger for sweets.&#xD;
  &#xD;
            -  Group II: no increased hunger for sweets. Increased hunger for sweets in group I is&#xD;
               defined as follows: &gt;= 20 energy percent (En%) by total sugar per day; In group II, no&#xD;
               increased hunger for sweets is defined as follows: &lt;= 10En% by total sugar per day.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other significant neurological diseases primarily affecting the central nervous system&#xD;
               (e.g., multiple sclerosis)&#xD;
  &#xD;
            -  Diagnosis of diabetes mellitus or prediabetes&#xD;
  &#xD;
            -  Use of medications that affect glucose metabolism, such as antidiabetics,&#xD;
               glucocorticoids, ciclosporin, tacrolimus, sirolimus, beta-blockers, thiazide&#xD;
               diuretics, beta-2 adrenoreceptor agonists, theophylline, Clozapine, olanzapine,&#xD;
               paliperidone, quetiapine, risperidone, tricyclic antidepressants, mirtazapine,&#xD;
               mianserin, carbamazepine, gabapentin, pregabalin, valproic acid, lithium,&#xD;
               antiretroviral drugs, statins&#xD;
  &#xD;
            -  cardiac or brain pacemakers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Eva Schäffer, MD</last_name>
      <phone>004943150023983</phone>
      <email>eva.schaeffer@uksh.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Julienne Haas, MD</last_name>
      <email>julienne.haas@uksh.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department for Neurology, University of Kiel</name>
        <address>
          <city>Kiel</city>
          <zip>24118</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eva Schäffer, Dr.</last_name>
        <phone>004943150023983</phone>
        <email>eva.schaeffer@uksh.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 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 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital Schleswig-Holstein</investigator_affiliation>
      <investigator_full_name>Eva Schaeffer</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Metabolic Diseases</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/NCT05998772
  org study id: D 537/23
  nct id: NCT05998772
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Many patients with Parkinson's Disease (PD) report an increased consumption of fast-acting
        sugars. This tendency to consume sweet, high-sugar foods occurs in some patients even before
        the onset of cardinal motor symptoms. Some recent studies have demonstrated that PD patients
        have an increased consumption of fast-acting carbohydrates compared to healthy controls.
        However, the reason for this change in eating behavior has not yet been adequately explained.
        It is discussed that the increased sugar intake leads to an increased dopamine release in the
        brain via an increase in insulin and thus to an improvement in clinical symptoms. This study
        investigates the influence of fast-acting carbohydrates on insulin and glucose blood levels
        as well as motor and non-motor symptoms in patients with PD using an oral glucose tolerance
        test and a placebo oral glucose tolerance test in a crossover design.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Concentration of Insulin in µU/mL
  time frame: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application
  description: Blood value
  measure: Motor function
  time frame: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60 and 120 minutes after application
  description: assessed by Unified Parkinson's Disease Rating Scale Part III, 0-132 points, higher points indicate worse motor function
  measure: Concentration of Blood Glucose in mg/dL
  time frame: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application
  description: Blood value
  measure: Cognitive function
  time frame: immediately before Application of oral glucose tolerance test and placebo as well as 60 minutes after application
  description: assessed by Montreal-Cognitive-Assessment-Test (MoCa), 0-30 points, higher points indicate better cognitive function
  arm group label: PD patients with craving for sweets
  arm group label: PD patients without craving for sweets
  intervention type: Diagnostic Test
  intervention name: Oral Glucose Tolerance Test
  description: Application of 82,5 g of glucose monohydrate solved in 300ml water
  arm group label: PD patients with craving for sweets
  arm group label: PD patients without craving for sweets
  intervention type: Other
  intervention name: Placebo Oral Glucose Tolerance Test
  description: Application of 125mg sucralose solved in 300ml water
  arm group label: PD patients with craving for sweets
  arm group label: PD patients without craving for sweets
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Eva Schäffer, MD
  phone: 004943150023983
  email: eva.schaeffer@uksh.de
  last name: Julienne Haas, MD
  email: julienne.haas@uksh.de
  facility: 
  status: Recruiting
  contact: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital Schleswig-Holstein
  investigator full name: Eva Schaeffer
  investigator title: Principal Investigator
  mesh term: Parkinson Disease
  mesh term: Metabolic Diseases