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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 14, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a dietary supplement called Myo-inositol (MI) on women diagnosed with gestational diabetes mellitus (GDM), which is high blood sugar that occurs during pregnancy. The goal is to see if taking MI can help reduce the need for insulin therapy, which some women with GDM require if diet and lifestyle changes aren’t enough to control their blood sugar. Previous research suggests that MI may significantly decrease the need for insulin in women with GDM, and this trial aims to confirm those findings by comparing MI to a placebo (a non-active treatment).

To participate in the trial, women must be at least 18 years old and have a singleton pregnancy (meaning they are pregnant with one baby), diagnosed with GDM according to specific blood sugar tests. Women who have already used insulin or certain other medications during this pregnancy, or have pre-existing diabetes, are not eligible. Participants will receive either MI or a placebo and will be monitored throughout the study to see how well their blood sugar levels are managed. This trial is important because it could offer a safer and more effective way to help women with GDM manage their condition and reduce reliance on insulin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Singleton pregnancy
• • GDM diagnosed during pregnancy according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e.
• • fasting plasma glucose between 92 mg/dL (5.1 mmol/L) and 125 mg/dL (6.9 mmol/L)
• • and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) ≥ 180 mg/dL (10.0 mmol/L)
• • and/or 2-hour plasma glucose value between 153 mg/dL (8.5 mmol/L) and 199 mg/dL ((11.0 mmol/L)
• • or overt diabetes according to 2-hours post OGTT plasma glucose value ≥ 200 mg/dl
• • 6 to 37 (+6 days) amenorrhea weeks at the time of randomization
• • Capacity for self-monitoring of blood glucose
• • Signed informed consent
• Exclusion Criteria:
• • Insulin use before randomization during this pregnancy
• • Use of other oral hypoglycemic agents during this pregnancy
• • Long time corticosteroid treatment
• • Pre-existing diabetes before pregnancy
• • Overt diabetes diagnosed during pregnancy according to fasting plasma glucose ≥ 126 mg/dL (7 mmol/l)
• • Lack of Social Insurance
• • Insufficient French understanding and speaking
• • Participant in another investigational drug study at inclusion visit
• • Fetal malformation diagnosed by previous fetal ultrasound
• • Personal history of any bariatric surgery
• • Hypersensitivity to any ingredient of dietary supplement formulation