Recruiting

Myo-inositol

Sponsor:

Tufts Medical Center

Code:

NCT06575868

Conditions

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Myo-inositol

Myo-inositol placebo

Study Details

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.

Conditions

Pregnancy Related

Study ID

NCT06575868

Start date

Mar 1, 2025

Status verified date

Apr, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Myo-inositol

placebo comparator: Placebo myo-inositol

Interventions

Myo-inositol

Patients would begin taking myoinositol upon recruitment

Myo-inositol placebo

Patients would begin taking placebo upon recruitment

Primary outcome measure

  • Eligibility [ Time Frame: 1 year ]
  • Glucose levels [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Zeinab Kassem, MD

617-636-9897zeinab.kassem@tuftsmedicine.org

Locations

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Zeunab Kassem

617-636-9897zeinab.kassem@tuftsmedicalcenter.org

More Information

Sponsor

Tufts Medical Center

Last update posted

Apr 29, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tufts Medical Center on 2025-04-29.