Myo-inositol During Pregnancy to Prevent Gestational Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorTufts Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Myo-inositol

    Dietary supplement

    Patients would begin taking myoinositol upon recruitment

  • Myo-inositol placebo

    Dietary supplement

    Patients would begin taking placebo upon recruitment

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Myo-inositolExperimental treatment 1 intervention
Group B: Placebo myo-inositolPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Eligibility

proportion of screened women who were eligible

Time frame
1 year
2

Glucose levels

Average glucose levels during CGM monitoring period for those enrolled

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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