RecruitingNot ApplicableNCT06575868

Myo-inositol During Pregnancy to Prevent Gestational Diabetes

Continuous Glucose Monitoring in Myo-inositol Supplemented Obese Pregnant Individuals: a Feasibility Pilot Randomized Control Trial


Sponsor

Tufts Medical Center

Enrollment

40 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria9

  • 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 Criteria8

  • 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

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Interventions

DIETARY_SUPPLEMENTMyo-inositol

Patients would begin taking myoinositol upon recruitment

DIETARY_SUPPLEMENTMyo-inositol placebo

Patients would begin taking placebo upon recruitment


Locations(1)

Tufts Medical Center

Boston, Massachusetts, United States

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NCT06575868


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