<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/NCT03763669</url>
  </required_header>
  <id_info>
    <org_study_id>UMessina</org_study_id>
    <nct_id>NCT03763669</nct_id>
  </id_info>
  <brief_title>Myoinositol Supplementation, Insulin Resistance and Fetal Sonographic Parameters in Gestational Diabetes Diet Treated</brief_title>
  <acronym>MYOGDM</acronym>
  <official_title>Myoinositol Supplementation, Insulin Resistance and Fetal Sonographic Parameters in Gestational Diabetes, Diet Treated: a Prospective, Randomized, Placebo-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Messina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Messina</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>
      The aim of this study is to verify the beneficial effects on insulin resistance and fetal&#xD;
      sonographic parameters of a diet supplementation of myoinositol taken during the third&#xD;
      trimester by pregnant women affected by gestational diabetes. Participants should be randomly&#xD;
      allocated to take either myoinositol or placebo twice/day for 8 weeks. The effect of&#xD;
      myoinositol will be checked in blood samples (insulinemia and Homeostasis Model Assessment -&#xD;
      Insulin Resistance &quot;HOMA-IR&quot;) and in fetal sonographic parameters after 4 and 8 weeks from&#xD;
      the beginning of the nutritional supplementation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Aim:&#xD;
&#xD;
      Gestational diabetes mellitus (GDM) is a carbohydrate intolerance diagnosed during pregnancy&#xD;
      that is not clearly an overt diabetes. It is characterized by an increase of the&#xD;
      physiological insulin resistance of the pregnancy status. Myo-Inositol is an insulin&#xD;
      sensitizing agent that ameliorate the insulin resistance. The investigators have already&#xD;
      demonstrated that myoinositol, administered in first half of pregnancy, may reduce insulin&#xD;
      resistance and GDM incidence in pregnant women at risk for family history, obesity and&#xD;
      overweight . But the experiences in women affected by GDM are few and controversial. So the&#xD;
      aim of this study is to test the effectiveness of myoinositol to ameliorate the insulin&#xD;
      resistance in GDM patients, diet treated. Moreover the investigators would like to verify the&#xD;
      impact of this nutritional supplementation on the fetal sonographic parameters.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      The study is a randomized, prospective, placebo-controlled trial, including the first 80&#xD;
      consecutive gestational diabetes patients diagnosed, according to the Italian Guidelines,&#xD;
      from November 2018 to December 2019, in the Department of Obstetric and Gynecology of Messina&#xD;
      University (ITALY). After an informed consent participants will be randomly assigned to&#xD;
      receive (n. 40) diet and folic acid (400 mcg per day) alone, or (n. 40) diet, folic acid (400&#xD;
      mcg per day) and myo-inositol (2 g. twice a day + 50 mg alfa-lactalbumin) supplementation.&#xD;
      Multiple pregnancy or known or suspected fetal congenital abnormality had been previously&#xD;
      excluded. The insulin sensitivity index (HOMA-IR) and fetal sonographic profile will be&#xD;
      monitor for each patient at GDM diagnosis and after 4 and 8 weeks of treatment. The pregnant&#xD;
      women who will delivery before the time treatment (8 weeks) or who need insulin will be&#xD;
      excluded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2018</start_date>
  <completion_date type="Actual">March 15, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 2020</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>
    <intervention_model_description>Patients will be randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) alone, or (n. 40) diet, folic acid (400 mcg per day) and myoinositol (2 g. twice a day + 50 mg alfa-lactalbumin) supplementation. The insulin sensitivity index (HOMA-IR) and fetal sonographic profile will be monitor for each patient at GDM diagnosis and after 4 and 8 weeks of treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Placebo administered</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin resistance</measure>
    <time_frame>Start point, and 8 weeks after</time_frame>
    <description>Change from baseline to 8 weeks of HOMA-IR calculated as glycemia (mmol/L) x insulinemia (mUI/L) / 22.5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fetal sonographic parameters</measure>
    <time_frame>Start point, 4 and 8 weeks after</time_frame>
    <description>Change from baseline to 4 and 8 weeks of Biparietal diameter (cm), Femur length (cm), Abdominal circumference (cm) and Subcutaneus tissue thickness (cm)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pregnant women randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) and myo-inositol supplementation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Pregnant women randomly assigned to receive (n. 40) only diet and folic acid (400 mcg per day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Myoinositol</intervention_name>
    <description>myo-inositol (2 g. twice a day)</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Folic acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo (for myoinositol)</intervention_name>
    <description>(twice a day)</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Folic acid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancy affected by gestational diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancy and known or suspected fetal malformations&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Obstetrics &amp; Gynecology - Policlinico &quot;G. Martino&quot;</name>
      <address>
        <city>Messina</city>
        <zip>98125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Santamaria A, Alibrandi A, Di Benedetto A, Pintaudi B, Corrado F, Facchinetti F, D'Anna R. Clinical and metabolic outcomes in pregnant women at risk for gestational diabetes mellitus supplemented with myo-inositol: a secondary analysis from 3 RCTs. Am J Obstet Gynecol. 2018 Sep;219(3):300.e1-300.e6. doi: 10.1016/j.ajog.2018.05.018. Epub 2018 May 30.</citation>
    <PMID>29859136</PMID>
  </reference>
  <reference>
    <citation>Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x.</citation>
    <PMID>21414183</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Messina</investigator_affiliation>
    <investigator_full_name>Francesco CORRADO</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Insulin resistance</keyword>
  <keyword>Fetal sonographic parameter</keyword>
  <keyword>Myoinositol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Folic Acid</mesh_term>
    <mesh_term>Vitamin B Complex</mesh_term>
    <mesh_term>Inositol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03763669
org study id: UMessina
nct id: NCT03763669
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to verify the beneficial effects on insulin resistance and fetal
      sonographic parameters of a diet supplementation of myoinositol taken during the third
      trimester by pregnant women affected by gestational diabetes. Participants should be randomly
      allocated to take either myoinositol or placebo twice/day for 8 weeks. The effect of
      myoinositol will be checked in blood samples (insulinemia and Homeostasis Model Assessment -
      Insulin Resistance "HOMA-IR") and in fetal sonographic parameters after 4 and 8 weeks from
      the beginning of the nutritional supplementation.
Background and Aim:

      Gestational diabetes mellitus (GDM) is a carbohydrate intolerance diagnosed during pregnancy
      that is not clearly an overt diabetes. It is characterized by an increase of the
      physiological insulin resistance of the pregnancy status. Myo-Inositol is an insulin
      sensitizing agent that ameliorate the insulin resistance. The investigators have already
      demonstrated that myoinositol, administered in first half of pregnancy, may reduce insulin
      resistance and GDM incidence in pregnant women at risk for family history, obesity and
      overweight . But the experiences in women affected by GDM are few and controversial. So the
      aim of this study is to test the effectiveness of myoinositol to ameliorate the insulin
      resistance in GDM patients, diet treated. Moreover the investigators would like to verify the
      impact of this nutritional supplementation on the fetal sonographic parameters.

      Design:

      The study is a randomized, prospective, placebo-controlled trial, including the first 80
      consecutive gestational diabetes patients diagnosed, according to the Italian Guidelines,
      from November 2018 to December 2019, in the Department of Obstetric and Gynecology of Messina
      University (ITALY). After an informed consent participants will be randomly assigned to
      receive (n. 40) diet and folic acid (400 mcg per day) alone, or (n. 40) diet, folic acid (400
      mcg per day) and myo-inositol (2 g. twice a day + 50 mg alfa-lactalbumin) supplementation.
      Multiple pregnancy or known or suspected fetal congenital abnormality had been previously
      excluded. The insulin sensitivity index (HOMA-IR) and fetal sonographic profile will be
      monitor for each patient at GDM diagnosis and after 4 and 8 weeks of treatment. The pregnant
      women who will delivery before the time treatment (8 weeks) or who need insulin will be
      excluded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) alone, or (n. 40) diet, folic acid (400 mcg per day) and myoinositol (2 g. twice a day + 50 mg alfa-lactalbumin) supplementation. The insulin sensitivity index (HOMA-IR) and fetal sonographic profile will be monitor for each patient at GDM diagnosis and after 4 and 8 weeks of treatment.
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: Placebo administered
measure: Insulin resistance
time frame: Start point, and 8 weeks after
description: Change from baseline to 8 weeks of HOMA-IR calculated as glycemia (mmol/L) x insulinemia (mUI/L) / 22.5
measure: Fetal sonographic parameters
time frame: Start point, 4 and 8 weeks after
description: Change from baseline to 4 and 8 weeks of Biparietal diameter (cm), Femur length (cm), Abdominal circumference (cm) and Subcutaneus tissue thickness (cm)
arm group label: Intervention
arm group type: Experimental
description: Pregnant women randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) and myo-inositol supplementation
arm group label: Control
arm group type: Placebo Comparator
description: Pregnant women randomly assigned to receive (n. 40) only diet and folic acid (400 mcg per day)
intervention type: Dietary Supplement
intervention name: Myoinositol
description: myo-inositol (2 g. twice a day)
arm group label: Intervention
other name: Folic acid
intervention type: Dietary Supplement
intervention name: Placebo (for myoinositol)
description: (twice a day)
arm group label: Control
other name: Folic acid
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: No
facility: 
country: Italy
citation: Santamaria A, Alibrandi A, Di Benedetto A, Pintaudi B, Corrado F, Facchinetti F, D'Anna R. Clinical and metabolic outcomes in pregnant women at risk for gestational diabetes mellitus supplemented with myo-inositol: a secondary analysis from 3 RCTs. Am J Obstet Gynecol. 2018 Sep;219(3):300.e1-300.e6. doi: 10.1016/j.ajog.2018.05.018. Epub 2018 May 30.
PMID: 29859136
citation: Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x.
PMID: 21414183
responsible party type: Principal Investigator
investigator affiliation: University of Messina
investigator full name: Francesco CORRADO
investigator title: Associate Professor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
mesh term: Insulin Resistance
mesh term: Folic Acid
mesh term: Vitamin B Complex
mesh term: Inositol
sharing ipd: Undecided