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Myoinositol Supplementation, Insulin Resistance and Fetal Sonographic Parameters in Gestational Diabetes Diet Treated (MYOGDM)

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ClinicalTrials.gov Identifier: NCT03763669
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Francesco CORRADO, University of Messina

Tracking Information
First Submitted Date  ICMJE November 19, 2018
First Posted Date  ICMJE December 4, 2018
Last Update Posted Date December 6, 2018
Actual Study Start Date  ICMJE November 14, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
Insulin resistance [ Time Frame: Start point, and 8 weeks after ]
Change from baseline to 8 weeks of HOMA-IR calculated as glycemia (mmol/L) x insulinemia (mUI/L) / 22.5
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
Insulin resistance [ Time Frame: Start point, and 8 weeks after ]
Change from baseline to 8 weeks of HOMA-IR
Change History Complete list of historical versions of study NCT03763669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
Fetal sonographic parameters [ Time Frame: Start point, 4 and 8 weeks after ]
Change from baseline to 4 and 8 weeks of Biparietal diameter (cm), Femur length (cm), Abdominal circumference (cm) and Subcutaneus tissue thickness (cm)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
Fetal sonographic parameters [ Time Frame: Start point, 4 and 8 weeks after ]
Biparietal diameter, Femur length, Abdominal circumference and Subcutaneus tissue thickness
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myoinositol Supplementation, Insulin Resistance and Fetal Sonographic Parameters in Gestational Diabetes Diet Treated
Official Title  ICMJE Myoinositol Supplementation, Insulin Resistance and Fetal Sonographic Parameters in Gestational Diabetes, Diet Treated: a Prospective, Randomized, Placebo-controlled Study
Brief Summary 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.
Detailed Description

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) 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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) 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.
Masking: Double (Participant, Care Provider)
Masking Description:
Placebo administered
Primary Purpose: Treatment
Condition  ICMJE Gestational Diabetes
Intervention  ICMJE
  • Dietary Supplement: Myoinositol
    myo-inositol (2 g. twice a day)
    Other Name: Folic acid
  • Dietary Supplement: Placebo (for myoinositol)
    (twice a day)
    Other Name: Folic acid
Study Arms  ICMJE
  • Experimental: Intervention
    Pregnant women randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) and myo-inositol supplementation
    Intervention: Dietary Supplement: Myoinositol
  • Placebo Comparator: Control
    Pregnant women randomly assigned to receive (n. 40) only diet and folic acid (400 mcg per day)
    Intervention: Dietary Supplement: Placebo (for myoinositol)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Singleton pregnancy affected by gestational diabetes

Exclusion Criteria:

  • Multiple pregnancy and known or suspected fetal malformations
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03763669
Other Study ID Numbers  ICMJE UMessina
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Francesco CORRADO, University of Messina
Study Sponsor  ICMJE University of Messina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Messina
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP