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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

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Dietary Supplement: Myoinositol Dietary Supplement: Placebo (for myoinositol) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Official Title: Myoinositol Supplementation, Insulin Resistance and Fetal Sonographic Parameters in Gestational Diabetes, Diet Treated: a Prospective, Randomized, Placebo-controlled Study
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Pregnant women randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) and myo-inositol supplementation
Dietary Supplement: Myoinositol
myo-inositol (2 g. twice a day)
Other Name: Folic acid

Placebo Comparator: Control
Pregnant women randomly assigned to receive (n. 40) only diet and folic acid (400 mcg per day)
Dietary Supplement: Placebo (for myoinositol)
(twice a day)
Other Name: Folic acid




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy affected by gestational diabetes

Exclusion Criteria:

  • Multiple pregnancy and known or suspected fetal malformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763669


Locations
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Italy
Department of Obstetrics & Gynecology - Policlinico "G. Martino" Recruiting
Messina, Italy, 98125
Contact: FRANCESCO CORRADO, professor    +39090221 ext 2182    fcorrado@unime.it   
Sub-Investigator: ROSARIO D'ANNA, professor         
Sub-Investigator: ANTONINO DI BENEDETTO, professor         
Sponsors and Collaborators
University of Messina

Publications:
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Responsible Party: Francesco CORRADO, Associate Professor, University of Messina
ClinicalTrials.gov Identifier: NCT03763669     History of Changes
Other Study ID Numbers: UMessina
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco CORRADO, University of Messina:
Insulin resistance
Fetal sonographic parameter
Myoinositol
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Pregnancy Complications
Folic Acid
Vitamin B Complex
Inositol
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances