Antenatal Myo-inositol Supplementation in Pre-existing Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Myo-inositol and folic acid supplement, Folic acid supplement.
- Who it may be relevant to
- Registry conditions: Perinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes Mellitus (T2DM). Basic parameters: 21 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Antenatal Myo-inositol Supplementation in Pre-existing Diabetes to Promote Normal Neonatal Outcomes
Overview
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.
Detailed description
The "Antenatal Myo-inositol supplementation in pre-existing diabetes to promote normal neonatal outcomes (AMulet)" pilot study aims to inform the design of a future double-blind randomised controlled trial which can assess the benefits of myo-inositol supplementation in pregnant women with T2DM. Despite provision of the international standard of care, pregnancies complicated by diabetes remain at high risk of adverse perinatal and neonatal outcomes. Offspring exposed to maternal diabetes in-utero also face increased risks of obesity and cardiometabolic diseases later in life. Myo-inositol supplementation has been trialled in pregnancy for the prevention and treatment of gestational diabetes, as well as in non-pregnant adults with T2DM, where improvements in glycaemic regulation and reduced insulin resistance have been observed with supplementation. However, myo-inositol supplementation has not yet been studied in pregnancies with T2DM. The primary aim of the AMulet trial would be to assess whether myo-inositol supplementation in pregnancies with T2DM can support normal fetal size and neonatal wellbeing. The present AMulet pilot study will assess the feasibility and acceptability of conducting such a trial and, additionally, seek to investigate the biological mechanisms through which myo-inositol may influence maternal and offspring health outcomes.
This pilot will recruit 182 pregnant women with T2DM between 12-16 weeks' gestation into a double-blind placebo-controlled randomized study. All participants will be randomly assigned to either an intervention group (receiving supplementation of myo-inositol with folic acid) or a control group (receiving supplementation with folic acid only). Supplementation will be in the form of similar looking capsules to be taken twice daily from recruitment until delivery.
Data and samples will be collected longitudinally across three study visits during pregnancy that will be arranged to coincide with routine antenatal clinic visits where possible, and a fourth visit soon after delivery. Additionally, there will be two re-supply visits and a post-delivery videoconference call. Other study data comprising antenatal, peripartum, fetal and neonatal outcomes will be extracted from medical records during pregnancy and post-delivery to assess the primary and secondary outcomes.
The binary composite primary outcome of normal fetal/neonatal size and wellbeing will be assessed by analyses on an intention-to-treat basis. Secondary outcomes, comprising maternity and other infant outcomes, will be assessed and quantified in terms of relative risk or mean differences between study groups. Adverse events, participant feedback as well as mechanistic understanding will be obtained.
This structured approach will inform the design of a future RCT by gathering data on feasibility and acceptability, identifying potential issues in protocols and data collection tools, and facilitating sample size calculations for the main trial which will aim to support the optimization of maternal and offspring health outcomes in pregnancies complicated by pre-existing T2DM.
Interventions
- Dietary supplement Myo-inositol and folic acid supplement
Participants 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. - Dietary supplement Folic acid supplement
Participants 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.
Primary outcome measures
- Composite of fetal/neonatal wellbeing [Time frame: From birth until 4 weeks post-delivery]
Secondary outcome measures (12)
- Intrauterine fetal growth and wellbeing as assessed by antenatal serial ultrasound scans [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.]
- Neonatal anthropometry and body composition [Time frame: Birth till 4-6 weeks post-delivery]
- Other perinatal and neonatal outcomes [Time frame: Birth till 4-6 weeks post-delivery]
- Fetal (cord) insulinaemia and C-peptide [Time frame: At birth]
- Maternal glycaemic control [Time frame: Up to 100 weeks duration, from within a year before conception (last recorded before conception) or early pregnancy (between conception and recruitment between ~12-16 weeks gestation), until the delivery of the baby (between 22-42 weeks gestation).]
- Hypertensive disorders of pregnancy [Time frame: Between time of recruitment (~12 to 16 weeks of gestation) and 4-6 weeks post-delivery]
- Gestational age at delivery and preterm prelabour rupture of membranes (PPROM) [Time frame: Between time of recruitment (~12 to 16 weeks of gestation) and delivery]
- Gestational weight gain [Time frame: Up to 100 weeks duration; From pre-pregnancy (last recorded weight before conception) or earliest recorded weight in pregnancy (between conception and recruitment) to the last recorded weight before delivery (22-42 weeks gestation).]
- Maternal depressive and anxiety symptoms [Time frame: Between time of recruitment (~12 to 16 weeks of gestation) and 4-6 weeks post-delivery]
- Mode of delivery [Time frame: At delivery]
- Postpartum blood loss [Time frame: At delivery and up to 4-6 weeks post-delivery]
- Other antenatal and peripartum events [Time frame: From conception to 4-6 weeks post-delivery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Singapore · 1 center
- National University Hospital — Singapore
Identifiers
NCT: NCT07241221 · 2024-4610