Informations générales (source: ClinicalTrials.gov)
Reduction of Insulin Therapy Under Myo-inositol for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. MYO-GDM Study (MYO-GDM)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mars 2020
mars 2025
04 juillet 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | COSSON Emmanuel | 12/04/2024 09:28:47 | Contacter | ||
| AP-HP - Hôpital Bicêtre | COSSON Emmanuel | 12/04/2024 09:28:47 | Contacter | ||
| AP-HP - Hôpital Jean Verdier | COSSON Emmanuel | 12/04/2024 09:28:47 | Contacter | ||
| HOPITAL NOVO | CAMPINOS / PONCELET | 04/07/2024 11:05:02 | Contacter | ||
Critères
Tous
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
- 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
- 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