<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/NCT01705639</url>
  </required_header>
  <id_info>
    <org_study_id>EudraCT-2011-005360-22</org_study_id>
    <nct_id>NCT01705639</nct_id>
  </id_info>
  <brief_title>Melatonin and Glucose Tolerance Among Individuals With a Variant of the MTNR1B Gene</brief_title>
  <acronym>MELAG</acronym>
  <official_title>Does Melatonin Treatment Affect Glucose Tolerance Among Individuals With a Variant (rs10830963) of the Melatonin Receptor 1B (MTNR1B) Gene?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Folkhalsan Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Helsinki</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants&#xD;
      of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3&#xD;
      months:&#xD;
&#xD;
        -  OGTT&#xD;
&#xD;
        -  questionnaires about sleep and activity&#xD;
&#xD;
        -  Actigraph&#xD;
&#xD;
        -  Anthropometry&#xD;
&#xD;
        -  Blood pressure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      http://www.sciencedirect.com/science/article/pii/S1550413116301607&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glucose tolerance</measure>
    <time_frame>3 months</time_frame>
    <description>Glucose tolerance is measured in OGTT: 0,30,60,90 and 120 minute values of glucose and insulin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sleep</measure>
    <time_frame>3 months</time_frame>
    <description>monitoring of sleep with questionnaires and activity monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity</measure>
    <time_frame>3 months</time_frame>
    <description>Activity and sleep of the subjects is recorded with Actigraph at 0 and 3 months</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Diabetes</condition>
  <condition>Glucose Tolerance</condition>
  <arm_group>
    <arm_group_label>Melatonin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>melatonin 4mg od for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melatonin</intervention_name>
    <description>All subjects receive the same dose of melatonin</description>
    <arm_group_label>Melatonin</arm_group_label>
    <other_name>Circadin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed informed concent&#xD;
&#xD;
          -  Known genotype for MTNR1B from the Botnia-ppp study&#xD;
&#xD;
          -  Age 18-75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Positive GAD-ab&#xD;
&#xD;
          -  Sever dysregulated hypertension&#xD;
&#xD;
          -  glaucoma&#xD;
&#xD;
          -  severe coronary heart disease or arrythmias&#xD;
&#xD;
          -  previous or ongoing severe ventricle or duodenal ulcer&#xD;
&#xD;
          -  psychosis or anxiety disorder&#xD;
&#xD;
          -  regular use of sleep pills, antidepressants or neuroleptics&#xD;
&#xD;
          -  creatinine &gt; 130 µmol/L&#xD;
&#xD;
          -  elevated liver enzymes (ASAT, ALAT, ALP, GT, bilirubin) &gt; 3 times reference value&#xD;
&#xD;
          -  inability to sign informed concent&#xD;
&#xD;
          -  other factor with according to the physician may affect treatment or results.&#xD;
&#xD;
          -  participation in other clinical study&#xD;
&#xD;
          -  allergy to melatonin or other substance in the capsule&#xD;
&#xD;
          -  hereditary galactose intolerance or glucose/galactose malabsorption&#xD;
&#xD;
          -  intention to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leif Groop, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>University of Lund, University of Helsinki</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tiinamaija Tuomi, Docent</last_name>
    <role>Study Director</role>
    <affiliation>Helsinki University Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bo Isomaa, Docent</last_name>
    <role>Principal Investigator</role>
    <affiliation>Folkhalsan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Botniacentret Jakobstad</name>
      <address>
        <city>Jakobstad</city>
        <zip>68660</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vasa health care centre</name>
      <address>
        <city>Vasa</city>
        <zip>65200</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <results_reference>
    <citation>Tuomi T, Nagorny CLF, Singh P, Bennet H, Yu Q, Alenkvist I, Isomaa B, Ostman B, Soderstrom J, Pesonen AK, Martikainen S, Raikkonen K, Forsen T, Hakaste L, Almgren P, Storm P, Asplund O, Shcherbina L, Fex M, Fadista J, Tengholm A, Wierup N, Groop L, Mulder H. Increased Melatonin Signaling Is a Risk Factor for Type 2 Diabetes. Cell Metab. 2016 Jun 14;23(6):1067-1077. doi: 10.1016/j.cmet.2016.04.009. Epub 2016 May 12.</citation>
    <PMID>27185156</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Helsinki</investigator_affiliation>
    <investigator_full_name>Tom Forsén</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>melatonin</keyword>
  <keyword>glucose tolerance</keyword>
  <keyword>sleep</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</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/NCT01705639
org study id: EudraCT-2011-005360-22
nct id: NCT01705639
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants
      of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3
      months:

        -  OGTT

        -  questionnaires about sleep and activity

        -  Actigraph

        -  Anthropometry

        -  Blood pressure
http://www.sciencedirect.com/science/article/pii/S1550413116301607
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Glucose tolerance
time frame: 3 months
description: Glucose tolerance is measured in OGTT: 0,30,60,90 and 120 minute values of glucose and insulin.
measure: sleep
time frame: 3 months
description: monitoring of sleep with questionnaires and activity monitoring
measure: Activity
time frame: 3 months
description: Activity and sleep of the subjects is recorded with Actigraph at 0 and 3 months
arm group label: Melatonin
arm group type: Experimental
description: melatonin 4mg od for 3 months
intervention type: Drug
intervention name: Melatonin
description: All subjects receive the same dose of melatonin
arm group label: Melatonin
other name: Circadin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leif Groop, Prof.
role: Study Chair
affiliation: University of Lund, University of Helsinki
last name: Tiinamaija Tuomi, Docent
role: Study Director
affiliation: Helsinki University Central Hospital
last name: Bo Isomaa, Docent
role: Principal Investigator
affiliation: Folkhalsan
facility: 
facility: 
country: Finland
citation: Tuomi T, Nagorny CLF, Singh P, Bennet H, Yu Q, Alenkvist I, Isomaa B, Ostman B, Soderstrom J, Pesonen AK, Martikainen S, Raikkonen K, Forsen T, Hakaste L, Almgren P, Storm P, Asplund O, Shcherbina L, Fex M, Fadista J, Tengholm A, Wierup N, Groop L, Mulder H. Increased Melatonin Signaling Is a Risk Factor for Type 2 Diabetes. Cell Metab. 2016 Jun 14;23(6):1067-1077. doi: 10.1016/j.cmet.2016.04.009. Epub 2016 May 12.
PMID: 27185156
responsible party type: Principal Investigator
investigator affiliation: University of Helsinki
investigator full name: Tom Forsén
investigator title: MD PhD
mesh term: Melatonin
sharing ipd: No