Clinical trial

Myo-inositol During Pregnancy to Prevent Gestational Diabetes

Recruiting now · Not applicable · 1 countries · Registry ID NCT06575868

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years

SexFemale

Healthy volunteersNot accepted

ConditionPregnancy Related

Full registry criteria

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

Treatments and study arms

Myo-inositol

Dietary Supplement

Patients would begin taking myoinositol upon recruitment

Myo-inositol placebo

Dietary Supplement

Patients would begin taking placebo upon recruitment

Primary outcomes

Eligibility1 year

proportion of screened women who were eligible

Glucose levels1 year

Average glucose levels during CGM monitoring period for those enrolled

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Tufts Medical Center🇺🇸 Boston, Massachusetts, United States

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Zeunab KassemContact

Email · Call 617-636-9897