Myo-inositol During Pregnancy to Prevent Gestational Diabetes
Recruiting · NCT06575868 · Interventional (participants receive a specific treatment) · Lead sponsor: Tufts Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Singleton gestations
- Women aged \> 18 years and \< 45 years
- Recruited before 16 weeks gestation
- bese (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 it is running
1 location listed across 1 US state.
- Tufts Medical Center - Boston, Massachusetts, United States