MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women With Polycystic Ovary Syndrome. (MYPP)
Gestational Diabetes Mellitus, Preeclampsia, Preterm Birth
About this trial
This is an interventional prevention trial for Gestational Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age
- Diagnosis of PCOS according to the Rotterdam consensus criteria and confirmed by a gynaecologist
- A viable singleton pregnancy confirmed by ultrasound
- Being able to initiate the use of study supplements between 8+0 and 16+0 weeks gestational age
- Ability to understand Dutch or English
- Ability to provide written informed consent
Exclusion Criteria:
- Diagnosis of pre-existent type-1 or 2 diabetes mellitus
- Pre-existent renal failure, defined as an estimated glomerular filtration rate (eGFR) less than 50 ml/min/1.73m2
- Use of myo-inositol supplements, other insulin-mimetics, hypoglycaemic agents (e.g. metformin) and/or systemic steroids, that cannot be discontinued at the time of inclusion
Sites / Locations
- Erasmus University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Myo-inositol and routinely recommended folic acid
Routinely recommended folic acid
Myo-inositol is a naturally occurring substance, with a structure quite similar to glucose, which forms an essential component of the cell membrane and is known to support several cellular processes in all living organisms. It is present in nature in high abundance and can be found in many food products. Myo-inositol was historically considered part of the vitamin-B complex and can safely be used as a dietary supplement. In humans, it is synthesized de novo from glucose-6-phosphate in many tissues, mainly in the kidney. Under normal circumstances, the kidneys produce large quantities of myo-inositol, estimated at about 4 grams of endogenous production per day. Myo-inositol has been shown to have a physiological role in supporting the effects of insulin in all living beings. It fulfils a second messenger role in the insulin signalling pathway by enhancing the translocation of GLUT-4 receptors on the plasma membrane and thereby facilitates the intra-cellular uptake of glucose.
Folic acid supplements are part of routine pregnancy care and frequently used as background supplements in previous trials on myo-inositol supplementation in pregnancy.