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RecruitingNot ApplicableNCT07241221

Antenatal Myo-inositol Supplementation in Pre-existing Diabetes

Antenatal Myo-inositol Supplementation in Pre-existing Diabetes to Promote Normal Neonatal Outcomes

Sponsor

National University Hospital, Singapore

Enrollment

182 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Perinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes Mellitus (T2DM)

Summary

This feasibility pilot study aims to gather data that can guide the design of a larger, more comprehensive trial to establish the effects of myo-inositol supplementation on supporting healthy outcomes in pregnancies complicated by Type 2 Diabetes Mellitus (T2DM). It seeks to assess myo-inositol's potential to support fetal and neonatal health, and optimise maternity outcomes as a complementary approach and adjuvant to existing diabetes mellitus therapies, as well as investigate the underlying biological mechanisms.

Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 45 Years

Inclusion Criteria7

  • Pregnant women aged 21 years to 45 years old at the time of recruitment
  • Ongoing, viable, singleton intrauterine pregnancy
  • Between 12+0 days-16+6 days weeks' gestation at recruitment
  • T2DM diagnosed by a documented 75g Oral Glucose Tolerance Test (OGTT) showing a fasting glucose of \>7 mmol/L or 2h glucose \>11.1 mmol/L, or an HbA1C \>6.5%, either prior to pregnancy or during the first 16 weeks of the index pregnancy
  • Intend to receive antenatal care and give birth at NUH
  • Willing to provide written, informed consent
  • Able to swallow capsules and comply with trial procedures

Exclusion Criteria2

  • Known or suspected fetal aneuploidy or genetic/structural anomaly
  • Severe allergy to food items requiring carriage of an Epipen at all times

Interventions

DIETARY_SUPPLEMENTMyo-inositol and folic acid supplement

Participants will take 4 capsules in the morning and 4 capsules in the evening, each capsule containing 500 mg of myo-inositol and 37.5 mcg of folic acid. Capsules are to be swallowed whole with a drink, starting from 12-16 weeks' gestation and continued until delivery.

DIETARY_SUPPLEMENTFolic acid supplement

Participants will take 4 capsules in the morning and 4 capsules in the evening, each capsule containing 37.5 mcg of folic acid. Capsules are to be swallowed whole with a drink, starting from 12-16 weeks' gestation and continued until delivery.

Locations(1)

National University Hospital

Singapore, Singapore, Singapore

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NCT07241221