NCT06575868Recruiting
Myo-inositol During Pregnancy to Prevent Gestational Diabetes
Continuous Glucose Monitoring in Myo-inositol Supplemented Obese Pregnant Individuals: a Feasibility Pilot Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 29 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 26 Aug 2024
- Start date
- 1 Mar 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Tufts Medical Center
- Diseases
- Obesity
- NCT number
- NCT06575868
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Mar 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking medications that impact body weight or metabolism (eg metformin)
Other illness
- Preexisting diabetes
Lab values
- Inability to tolerate glucose tolerance test
Other
- Multiple gestation
- Adults unable to consent (cognitively impaired adults)
- Wards of the state
- Non-viable neonates
- Neonates of uncertain viability
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.