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Myo-inositol During Pregnancy to Prevent Gestational Diabetes

Sponsored by Tufts Medical Center

About this trial

Last updated a year ago

Study ID

STUDY00005304

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18 to 45 Years
Female

Trial Timing

Started a year ago

What is this trial 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.

What are the participation requirements?

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