Myo-inositol supplementation during pregnancy for women with Type 2 diabetes
Antenatal Myo-inositol Supplementation in Pre-existing Diabetes to Promote Normal Neonatal Outcomes
This pilot will test whether taking myo-inositol supplements during pregnancy helps women with Type 2 diabetes support fetal growth and newborn wellbeing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | Female |
| Sponsor | National University Hospital, Singapore Academic / other |
| Locations | 1 site (Singapore, Singapore) |
| Trial ID | NCT07241221 on ClinicalTrials.gov |
What this trial studies
AMulet is a double-blind, placebo-controlled pilot randomized trial enrolling about 182 pregnant women with pre-existing Type 2 diabetes between 12+0 and 16+6 weeks' gestation at a single center in Singapore. Participants are randomized to receive myo-inositol plus folic acid or folic acid alone and will take capsules through pregnancy, with outcomes measured at birth and biological samples collected to explore mechanisms. The pilot primarily examines feasibility and acceptability to inform the design and sample size of a larger definitive trial while collecting preliminary data on fetal size, neonatal wellbeing, and maternal glycaemic markers. Findings will guide whether and how a larger trial should proceed.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 21–45 with a singleton viable pregnancy at 12+0 to 16+6 weeks, diagnosed with pre-existing Type 2 diabetes, who plan antenatal care and delivery at National University Hospital Singapore and can swallow capsules.
Not a fit: Women with Type 1 diabetes, gestational diabetes only, multiple pregnancies, known fetal anomalies, severe food allergies requiring an epipen, or those unable to attend NUH are unlikely to receive benefit from this study.
Why it matters
Potential benefit: If effective, supplementation could reduce the risk of abnormal fetal growth and improve newborn health at birth, potentially lowering long-term metabolic risk for the child.
How similar studies have performed: Myo-inositol has shown positive effects in some trials for preventing gestational diabetes and improving insulin sensitivity in non-pregnant Type 2 diabetes, but it has not previously been studied in pregnancies with pre-existing Type 2 diabetes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Singapore, Singapore
- National University Hospital — Singapore, Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Shiao-Yng Chan, MBBChir (UK), FRCOG (UK), PhD — National University of Singapore, National University Hospital Singapore, Institute for Human Development and Potential (A*STAR)
- Study coordinator: Gladys Woon, Bsc
- Email: gladys_woon@nuhs.edu.sg
- Phone: +65 6516 4134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.