Antenatal Myo-inositol Supplementation in Pre-existing Diabetes
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Perinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes Mellitus (T2DM)
In brief
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.
Key facts
- Study ID
- NCT07241221
- Run by
- National University Hospital, Singapore
- People needed
- 182
- Starts
- 2025-12-01
- Expected to finish
- 2029-08-31
- Last updated by the study team
- 2025-12-09
Who can join
Age: 21 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Known or suspected fetal aneuploidy or genetic/structural anomaly
- Severe allergy to food items requiring carriage of an Epipen at all times
Where it is running
- National University Hospital — Singapore, Singapore, Singapore (enrolling)
Full record on ClinicalTrials.gov
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