Pregnancy Related
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTMyo-inositol
Patients would begin taking myoinositol upon recruitment
DIETARY_SUPPLEMENTMyo-inositol placebo
Patients would begin taking placebo upon recruitment
Sponsors
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility | 1 year | proportion of screened women who were eligible |
| Glucose levels | 1 year | Average glucose levels during CGM monitoring period for those enrolled |
Countries
United States
Contacts
Primary ContactZeinab Kassem, MD
Outcome results
None listed