Myo-inositol for Reduction of Insulin Therapy in Gestational Diabetes Mellitus — MYO-GDM  

Gestational Diabetes Mellitus Clinical Trial

Official title: Reduction of Insulin Therapy Under Myo-inositol for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. MYO-GDM Study

Status Recruiting

Clinical Trial Summary

Gestational diabetes mellitus (GDM) is defined as hyperglycemia first-diagnosed during pregnancy. Glycemic control reduces GDM-related complications. With the new diagnostic criteria of GDM, up to 25% of pregnant women have GDM, whereas it was previously 6-10% in France. Therefore caring for women with GDM is very time-consuming. Therapeutic strategy includes dietary and lifestyle measures and additional insulin therapy for 15 to 40% of the women with GDM if the glycemic targets are not achieved after a period of 1 to 2 weeks of diet. Insulin therapy is imperfect for the following main reasons: need for education (i.e. subcutaneous administration, dose titration), hypoglycemia and weight gain, limited acceptance and high cost. Psychosocial deprivation is associated with more cases of GDM and health accessibility may be unequal.

MYO-INOSITOL (MI) is an oral dietary supplement, which reduces insulin resistance. Women with GDM are deficient in MI. MI supplementation safely prevents GDM by 65 to 87% in high-risk women. A pilot study has shown a 75% reduction of the need for insulin during GDM not controlled by diet.

The coordinator investigator propose here, for the first time, a randomized controlled study evaluating MI versus placebo in women with newly diagnosed GDM.

Clinical Trial Description

Prospective, multicenter, superiority, randomised, double blind study with two arms.

1. In the 17 participating centers (15 in France and 2 in Belgium): selection of women with GDM between 6 to 37 (+6 days) amenorrhea weeks

2. Explanation of protocol, with signature of consent in case of acceptation.

3. Randomization

• Experimental group: The women will receive 2 caps of MI with acid folic a day, until delivery

• Control group: The women will receive 2 caps of placebo (containing only acid folic) a day, until delivery

In both arms, the participants will be routinely followed up during pregnancy:

• diet education,

• self-monitoring of blood glucose before and after meals

• and during follow-up insulin therapy if glucose value targets are unmet

4. Routine monitoring of the women with GDM in both arms, up to delivery, without use of other oral hypoglycemic agents during pregnancy.

At delivery:

• MI (or placebo) will be stopped

• If applicable, maternal blood samples will be collected at the same time as the sample routinely collected just before delivery for irregular agglutinin test measurement, when the women are perfused and cord fluid will be collected at the same as cord fluid pH is routinely measured just after delivery. The aliquots will be transported to the "Centre de Ressources Biologiques"(CRB) of the Jean Verdier Hospital

• Events during pregnancy will be collected

5. Last visit three months after delivery. Oral glucose tolerance test, anthropometric measures for women and their child. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

• NCT number: NCT03875755
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Emmanuel COSSON, MD-PhD
• Phone: 1 48 02 65 80
• Email: emmanuel.cosson@aphp.fr
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2020
• Completion date: March 4, 2025