Continuous Glucose Monitoring in Obese Pregnant Women with Myo-inositol
Myo-inositol
+ Myo-inositol placebo
Prevention Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy 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