Recruiting

Continuous Glucose Monitoring in Obese Pregnant Women with Myo-inositol

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What is being tested

Myo-inositol

+ Myo-inositol placebo

Dietary Supplement
Who is being recruted

From 18 to 45 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorTufts Medical Center
Study ContactZeinab Kassem, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2025

Actual date on which the first participant was enrolled.

This study is exploring the use of a compound called myo-inositol in pregnant individuals who are obese. Myo-inositol is similar to insulin and can be found naturally in the body and in our diet. It helps the body use insulin more effectively, which is particularly useful for managing blood sugar levels. This study is important because it aims to see if myo-inositol can help improve insulin sensitivity and blood sugar control in pregnant individuals, potentially preventing gestational diabetes, a condition that can complicate pregnancies and affect both mother and baby. Participants in this study are randomly assigned to receive either myo-inositol or a placebo, which is a substance with no active ingredients, to compare the effects. This approach is called a double-blind randomized control trial, meaning neither the participants nor the researchers know who is receiving the actual supplement or the placebo. The study uses continuous glucose monitoring to track blood sugar levels over time, helping to assess how well myo-inositol works in managing these levels. The trial is designed to ensure safety and accuracy while gathering data on the potential benefits of myo-inositol as a preventative measure for gestational diabetes.

Official TitleContinuous Glucose Monitoring in Myo-inositol Supplemented Obese Pregnant Individuals: a Feasibility Pilot Randomized Control Trial
NCT06575868
Principal SponsorTufts Medical Center
Study ContactZeinab Kassem, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Tufts Medical Center

Boston, United StatesOpen Tufts Medical Center in Google Maps
Recruiting
One Study Center
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