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NCT Number: NCT03763669

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

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics & Gynecology - Policlinico "G. Martino"

Messina, 98125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton pregnancy affected by gestational diabetes

Exclusion criteria

  • Multiple pregnancy and known or suspected fetal malformations

Treatment and study plan

Myoinositol

Dietary Supplement

myo-inositol (2 g. twice a day)

Other names: Folic acid

Placebo (for myoinositol)

Dietary Supplement

(twice a day)

Other names: Folic acid

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

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

Acronym: MYOGDM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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