Myo-inositol During Pregnancy to Prevent Gestational Diabetes
Status
Conditions
Treatments
Details and patient eligibility
About
Myoinositol is an insulin-like compound that is present in both plant and animal cells. Humans synthesize it naturally, but it is also obtained in our diet. It works through an intracellular signaling pathway to increase insulin sensitivity. Myoinositol has been used as an over-the-counter (OTC) supplement in the management of polycystic ovarian syndrome due to this effect. Myoinositol has also been shown to improve glycemic profiles in pregnant euglycemic women and well as improve insulin sensitivity in pregnant patients with gestational diabetes mellitus (GDM).
This is a double blind RCT offering myo-inositol or placebo to those who are eligible and enrolled.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Singleton gestations
Women aged > 18 years and < 45 years
Recruited before 16 weeks gestation
Obese (pre-pregnancy BMI ≥ 30)
Receiving prenatal care at Tufts Medical Center
Planning to give birth at Tufts Medical Center
Can tolerate glucose tolerance test
Willing and able to wear CGM
Willing and able to sign informed consent
Exclusion criteria
Multiple gestation
Preexisting diabetes
Taking medications that impact body weight or metabolism (eg metformin)
Inability to tolerate glucose tolerance test
Adults unable to consent (cognitively impaired adults)
Wards of the state
Non-viable neonates
Neonates of uncertain viability
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Zeinab Kassem, MD
Data sourced from clinicaltrials.gov
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