Antenatal Myo-inositol Supplementation in Pre-existing Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-45
SponsorNational University Hospital, Singapore
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known or suspected fetal aneuploidy or genetic/structural anomaly
Severe allergy to food items requiring carriage of an Epipen at all times
Trial design
Design model
Parallel
Treatments tested in this trial
Myo-inositol and folic acid supplement
Dietary supplementParticipants 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.
Folic acid supplement
Dietary supplementParticipants 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.
Treatment groups
182 Participants
are divided into 2 treatment groupsGroup A: Intervention (myo-inositol and folic acid supplement)Experimental treatment 1 intervention
Group B: Control (folic acid supplement)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite of fetal/neonatal wellbeing
Number and proportion of cases displaying all of the following outcomes of (1) being appropriately-grown-for-gestational-age (AGA; 10th-90th centile in weight) at birth; (2) delivered at term (37 weeks+0 days gestation or more); (3) no admission to the neonatal unit in the first 4 weeks of life; and (4) alive at delivery and at 4 weeks post-delivery. Results will also be presented as a relative risk with 95% confidence intervals, with and without adjustment for important covariates, as well as with and without stratification for baseline HbA1C (high/low), pre-pregnancy insulin treatment, duration since T2DM diagnosis (\<1y, \>1y), and in per-protocol analyses.
Time frame
From birth until 4 weeks post-deliverySecondary outcomes
1
Intrauterine fetal growth and wellbeing as assessed by antenatal serial ultrasound scans
Mean differences in cross-sectional comparisons and longitudinal changes in measured biometric parameters, derived size/weight estimates and Doppler assessments, as well as differences in the velocity of growth, peak/nadir in the velocity of growth and its gestational timing, and the fastest/slowest change in growth velocity and its gestational timing, with and without adjustment for important covariates.
Time frame
Up to 38 weeks duration, from the earliest scan in pregnancy ~5-6 weeks' gestation until delivery of the baby between 22-42 weeks' gestation.2
Neonatal anthropometry and body composition
Number and proportion, and relative risks, of macrosomia (birthweight \>4000 g), low birthweight (\<2500 g), Large-for-Gestational-Age (LGA; birthweight \>90th centile), and Small-for-Gestational-Age (SGA; birthweight \<10th centile), and mean differences or categorically-defined outcomes of birthweight, birth length, head circumference, abdominal circumference, mid-arm circumference, skinfold thickness, fat mass, fat-free mass, and percentage body fat (assessed by air displacement plethysmography, PEAPOD), with and without adjustment for important covariates. Continuous data to be standardised to z-scores, where appropriate.
Time frame
Birth till 4-6 weeks post-delivery3
Other perinatal and neonatal outcomes
Number and proportion, and relative risks, of neonatal respiratory distress (aetiology and treatment required), neonatal hypoglycemia, number of hypocount values \<2.6 mmol/L, hyperbilirubinemia requiring phototherapy or exchange transfusion, neonatal sepsis (early and late onset, aetiology and treatment required), shoulder dystocia, birth trauma, hypoxic ischaemic encephalopathy/intracranial haemorrhage, neonatal unit admission, or stillbirth/neonatal death, as well as mean differences in the levels of glycaemia and bilirubinaemia, and in the duration of respiratory support, phototherapy and neonatal unit/hospital stay, with and without adjustment for important covariates. Continuous data to be standardised to z-scores, where appropriate.
Time frame
Birth till 4-6 weeks post-delivery4
Fetal (cord) insulinaemia and C-peptide
Number and proportion, and relative risks of fetal hyperinsulinaemia or high C-peptide concentration, and mean difference in insulin or C-peptide concentrations in umbilical cord blood (where obtainable); with and without adjustment for important covariates
Time frame
At birthSponsors and contacts
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National University Hospital, Singapore
Lead sponsor
National University of Singapore
Collaborator
Source ClinicalTrials.gov