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

• ClinicalTrials.gov Identifier: NCT03763669
• Recruitment Status: Completed
• First Posted: December 4, 2018
• Last Update Posted: March 24, 2020
• Sponsor: University of Messina
• Information provided by (Responsible Party): Francesco CORRADO, University of Messina

Study Description

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 + 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 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 + 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 (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
• Actual Primary Completion Date: March 15, 2020
• Actual Study Completion Date: March 15, 2020

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

Italy

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

Messina, Italy, 98125

Sponsors and Collaborators

University of Messina

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

D'Anna R, Corrado F, Loddo S, Gullo G, Giunta L, Di Benedetto A. Myoinositol plus α-lactalbumin supplementation, insulin resistance and birth outcomes in women with gestational diabetes mellitus: a randomized, controlled study. Sci Rep. 2021 Apr 23;11(1):8866. doi: 10.1038/s41598-021-88329-x.

• Responsible Party: Francesco CORRADO, Associate Professor, University of Messina
• ClinicalTrials.gov Identifier: NCT03763669
• Other Study ID Numbers: UMessina
• First Posted: December 4, 2018
• Last Update Posted: March 24, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Diabetes, Gestational; Diabetes Mellitus; Insulin Resistance; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Pregnancy Complications; Folic Acid; Vitamin B Complex; Inositol; Hematinics; Vitamins; Micronutrients; Physiological Effects of Drugs