NCT07241221 Antenatal Myo-inositol Supplementation in Pre-existing Diabetes
| NCT ID | NCT07241221 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University Hospital, Singapore |
| Condition | Perinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 182 participants |
| Start Date | 2025-12 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 182 participants in total. It began in 2025-12 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria * 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 Criteria * Known or suspected fetal aneuploidy or genetic/structural anomaly * Severe allergy to food items requiring carriage of an Epipen at all times
Contact & Investigator
Shiao-Yng Chan, MBBChir (UK), FRCOG (UK), PhD
PRINCIPAL INVESTIGATOR
National University of Singapore, National University Hospital Singapore, Institute for Human Development and Potential (A*STAR)
Frequently Asked Questions
Who can join the NCT07241221 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 45 Years, studying Perinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07241221 currently recruiting?
Yes, NCT07241221 is actively recruiting participants. Contact the research team at gladys_woon@nuhs.edu.sg for enrollment information.
Where is the NCT07241221 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07241221 clinical trial?
NCT07241221 is sponsored by National University Hospital, Singapore. The principal investigator is Shiao-Yng Chan, MBBChir (UK), FRCOG (UK), PhD at National University of Singapore, National University Hospital Singapore, Institute for Human Development and Potential (A*STAR). The trial plans to enroll 182 participants.
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