Continuous Glucose Monitoring in Myo-inositol Supplemented Obese Pregnant Individuals: a Feasibility Pilot Randomized Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Tufts Medical Center
RECRUITING
Boston
Contact Information
Primary
Zeinab Kassem, MD
zeinab.kassem@tuftsmedicine.org
617-636-9897
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 40
Treatments
Experimental: Myo-inositol
Placebo_comparator: Placebo myo-inositol
Sponsors
Leads: Tufts Medical Center

This content was sourced from clinicaltrials.gov

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