Using Myo-inositol to Reduce Insulin Needs in Pregnant Women with Diabetes
Reduction of Insulin Therapy Under Myo-inositol for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. MYO-GDM Study
This study tests if taking Myo-inositol can help pregnant women with diabetes lower their need for insulin while managing their blood sugar.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1080 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Bobigny) |
| Trial ID | NCT03875755 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Myo-inositol (MI) supplementation in reducing the need for insulin therapy in women diagnosed with gestational diabetes mellitus (GDM). The study involves a multicenter, randomized, double-blind design where participants are assigned to receive either MI or a placebo alongside standard dietary education and blood glucose monitoring. The trial aims to assess the impact of MI on glycemic control and related pregnancy outcomes, with follow-up extending three months post-delivery. The goal is to provide a safer and more acceptable alternative to insulin therapy for managing GDM.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older who have been diagnosed with gestational diabetes according to specific glucose criteria.
Not a fit: Patients who have already been using insulin or other oral hypoglycemic agents during their pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the reliance on insulin therapy for pregnant women with gestational diabetes, leading to better health outcomes for both mothers and their babies.
How similar studies have performed: Previous studies have indicated that Myo-inositol supplementation may be beneficial in managing insulin resistance, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bobigny
- Hôpital Avicenne — Bobigny, France (Recruiting)
Study contacts
- Principal investigator: Emmanuel COSSON, MD-PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Emmanuel COSSON, MD-PhD
- Email: emmanuel.cosson@aphp.fr
- Phone: 1 48 02 65 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.