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

Gestational Diabetes Clinical Trial

— MYOGDM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763669
• Other study ID #: UMessina
• Status: Completed
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2020
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy affected by gestational diabetes

Exclusion Criteria:

• Multiple pregnancy and known or suspected fetal malformations

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Insulin Resistance

Intervention

Dietary Supplement:
• Myoinositol
myo-inositol (2 g. twice a day)
• Placebo (for myoinositol)
(twice a day)

Locations

Country	Name	City	State
Italy	Department of Obstetrics & Gynecology - Policlinico "G. Martino"	Messina

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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