Myo-inositol During Pregnancy to Prevent Gestational Diabetes

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts Medical Center
Study ID
NCT06575868
Status
Recruiting
Apply to this trial

Conditions

  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Myo-inositol — DIETARY_SUPPLEMENT
    Patients would begin taking myoinositol upon recruitment
  • Myo-inositol placebo — DIETARY_SUPPLEMENT
    Patients would begin taking placebo upon recruitment

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Myo-inositol
  • Placebo Comparator: Placebo myo-inositol

Primary Outcome Measure

Eligibility [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111
Zeunab Kassem
[email protected]
617-636-9897

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By research site
Tufts Medical Center· Boston, MA

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