Continuous Glucose Monitoring in Myo-inositol Supplemented Obese Pregnant Individuals: a Feasibility Pilot Randomized Control Trial
| Registry | NCT06575868 |
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| Status | Recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: triple, prevention |
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| Enrollment | 40 (Estimated) |
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| Sponsor | Tufts Medical Center (Other) |
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| Conditions | Pregnancy Related |
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| Interventions | Myo-inositol, Myo-inositol placebo (Dietary supplement) |
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| Dates | start 2025-03-01, primary completion 2026-12-31 (estimated), completion 2027-06-30 (estimated), first posted 2024-08-28, last updated 2025-04-29 |
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| Locations | 1 site in United States |
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-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Myo-inositol | Experimental | Dietary Supplement: Myo-inositol | |
| Placebo myo-inositol | Placebo comparator | Dietary Supplement: Myo-inositol placebo | |
- Myo-inositol (Dietary supplement): Patients would begin taking myoinositol upon recruitment
- Myo-inositol placebo (Dietary supplement): Patients would begin taking placebo upon recruitment
+Outcome measures
Primary outcomes
- Eligibility [1 year]: proportion of screened women who were eligible
- Glucose levels [1 year]: Average glucose levels during CGM monitoring period for those enrolled
+Eligibility
Sex: Female, ages: 18 Years to 45 Years
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
+Locations (1)
| Facility | City | Country | Status |
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| Tufts Medical Center | Boston, Massachusetts | United States | Recruiting |
+Publications
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