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NCT Number: NCT06575868

Myo-inositol During Pregnancy to Prevent Gestational Diabetes

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.

Recruiting

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Key information

Conditions

Pregnancy Related

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location status: Recruiting

Location contact

Zeunab Kassem

CONTACT

[email protected]

617-636-9897

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Eligibility

    Time frame: 1 year

    proportion of screened women who were eligible

  2. Glucose levels

    Time frame: 1 year

    Average glucose levels during CGM monitoring period for those enrolled

Study contacts

Contact information is provided by the study sponsor or research team.

Zeinab Kassem, MD

CONTACT

[email protected]

617-636-9897

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 28, 2024
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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