<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/NCT03002545</url>
  </required_header>
  <id_info>
    <org_study_id>DiaMag 2017</org_study_id>
    <nct_id>NCT03002545</nct_id>
  </id_info>
  <brief_title>Magnesium Supplementation in Type II Diabetes</brief_title>
  <official_title>Effects of a 12-week Supplementation With 400 mg Magnesium From Magnesium Citrate on Blood Sugar, Blood Pressure and Expression of Magnesium-sensitive Genes in Patients With Type II Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Protina Pharmazeutische GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Protina Pharmazeutische GmbH</source>
  <brief_summary>
    <textblock>
      This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium&#xD;
      from organic magnesium citrate affects blood glucose control and insulin resistance within&#xD;
      patients with type 2 diabetes (HbA1c&gt; 6%) and how the expression of certain Mg-sensitive&#xD;
      transporting genes is affected .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The examinations are carried out in 50 subjects aged 20-80 years with existing type 2&#xD;
      diabetes (HbA1c&gt; 6%). The target parameters are determined in the blood. Blood sampling takes&#xD;
      place at confinement, after 6 weeks and at the end of the study (week 12). In addition, blood&#xD;
      pressure is determined and general health condition of each subject is recorded by a&#xD;
      standardized questionnaire (SF-36).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">March 2019</primary_completion_date>
  <phase>N/A</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>blood sampling</measure>
    <time_frame>12 weeks</time_frame>
    <description>measurement of type II Diabetes relevant Parameters including Glucose, HbA1c, HOMA-IR, magnesium-sensitive gene expression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood pressure measurement</measure>
    <time_frame>12 weeks</time_frame>
    <description>measurement of blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>questionnaire SF-36</measure>
    <time_frame>12 weeks</time_frame>
    <description>questionnaire is used to assess the physiological health Status of patients</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Effect of Magnesium in Diabetes</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>identically tasting and looking Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Magnesium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Supplementation with 400 mg Magnesium from Magnesium citrate once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Magnesium citrate</intervention_name>
    <arm_group_label>Magnesium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type II Diabetics (HbA1c &gt; 6%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy, lactation&#xD;
&#xD;
          -  persons with severe renal impairment (glomerular filtration rate &lt;30 ml / min)&#xD;
&#xD;
          -  use of insulin, oral antidiabetic drugs, diuretics, antacids or proton pump inhibitors&#xD;
             within 4 weeks prior to study start and during the study&#xD;
&#xD;
          -  intake of vitamin supplements, dietary supplements, mineral products or possibly&#xD;
             enriched foods containing Magnesium within 4 weeks before study start and during the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St. Anna Hospital</name>
      <address>
        <city>Herne</city>
        <zip>44649</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Magnesium</keyword>
  <keyword>Type II diabetes</keyword>
  <keyword>magnesium-sensitive genes</keyword>
  <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>Magnesium citrate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03002545
org study id: DiaMag 2017
nct id: NCT03002545
lead sponsor: 
This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium
      from organic magnesium citrate affects blood glucose control and insulin resistance within
      patients with type 2 diabetes (HbA1c> 6%) and how the expression of certain Mg-sensitive
      transporting genes is affected .
The examinations are carried out in 50 subjects aged 20-80 years with existing type 2
      diabetes (HbA1c> 6%). The target parameters are determined in the blood. Blood sampling takes
      place at confinement, after 6 weeks and at the end of the study (week 12). In addition, blood
      pressure is determined and general health condition of each subject is recorded by a
      standardized questionnaire (SF-36).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: blood sampling
time frame: 12 weeks
description: measurement of type II Diabetes relevant Parameters including Glucose, HbA1c, HOMA-IR, magnesium-sensitive gene expression
measure: blood pressure measurement
time frame: 12 weeks
description: measurement of blood pressure
measure: questionnaire SF-36
time frame: 12 weeks
description: questionnaire is used to assess the physiological health Status of patients
arm group label: Placebo
arm group type: Placebo Comparator
description: identically tasting and looking Placebo
arm group label: Magnesium
arm group type: Active Comparator
description: Supplementation with 400 mg Magnesium from Magnesium citrate once daily
intervention type: Dietary Supplement
intervention name: Magnesium citrate
arm group label: Magnesium
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Magnesium citrate