Antenatal Myo-inositol Supplementation in Pre-existing Diabetes
Recruiting · NCT07241221 · Interventional (participants receive a specific treatment) · Lead sponsor: National University Hospital, Singapore
View the official record on ClinicalTrials.gov →Interventions studied
Folic acid supplementMyo-inositol and folic acid supplement
What this trial is about
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.
Who can take part
Age range
21 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- National University Hospital - Singapore, Singapore, Singapore