Using myo-inositol during pregnancy to prevent gestational diabetes
Continuous Glucose Monitoring in Myo-inositol Supplemented Obese Pregnant Individuals: a Feasibility Pilot Randomized Control Trial
This study tests if taking myo-inositol during pregnancy can help prevent gestational diabetes in obese women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Tufts Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06575868 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of myo-inositol, an insulin-like compound, on preventing gestational diabetes in pregnant women. It is a double-blind randomized controlled trial where participants will receive either myo-inositol or a placebo. The study aims to assess whether myo-inositol can improve insulin sensitivity and glycemic profiles in obese pregnant women. Participants will be monitored throughout their pregnancy to evaluate the outcomes related to gestational diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are obese women aged 18 to 45 years with singleton pregnancies, who are receiving prenatal care at Tufts Medical Center.
Not a fit: Patients with preexisting diabetes or those taking medications that affect metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of gestational diabetes among pregnant women, leading to healthier pregnancies and outcomes.
How similar studies have performed: Previous studies have shown promising results with myo-inositol in improving insulin sensitivity in pregnant women, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Zeinab Kassem, MD
- Email: zeinab.kassem@tuftsmedicine.org
- Phone: 617-636-9897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.