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

Study Overview
=================
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 + 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.

Official Title
-----------------
Myoinositol Supplementation, Insulin Resistance and Fetal Sonographic Parameters in Gestational Diabetes, Diet Treated: a Prospective, Randomized, Placebo-controlled Study

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Myoinositol
* Dietary Supplement: Placebo (for myoinositol)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy affected by gestational diabetes Exclusion Criteria: Multiple pregnancy and known or suspected fetal malformations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Pregnant women randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) and myo-inositol supplementation | Dietary Supplement: Myoinositol<br>* myo-inositol (2 g. twice a day)<br>* Other names: Folic acid;|
| Placebo Comparator: Control<br>Pregnant women randomly assigned to receive (n. 40) only diet and folic acid (400 mcg per day) | Dietary Supplement: Placebo (for myoinositol)<br>* (twice a day)<br>* Other names: Folic acid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | Change from baseline to 8 weeks of HOMA-IR calculated as glycemia (mmol/L) x insulinemia (mUI/L) / 22.5 | Start point, and 8 weeks after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal sonographic parameters | Change from baseline to 4 and 8 weeks of Biparietal diameter (cm), Femur length (cm), Abdominal circumference (cm) and Subcutaneus tissue thickness (cm) | Start point, 4 and 8 weeks after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin resistance, Fetal sonographic parameter, Myoinositol