Antenatal Myo-inositol Supplementation in Pre-existing Diabetes

NCT07241221 | Recruiting

• 1 other identifier: 2024-4610
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes Mellitus (T2DM)

Keywords

Diabetes; Pregnancy; Myo-inositol; Folic acid; Dietary Supplement; Birthweight; Prematurity; Neonatal Intensive Care Unit Admission; Stillbirth; Neonatal Death; Neonatal Complications; Maternity Complications

Outcome Measures

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.

  From birth until 4 weeks post-delivery

Secondary Outcomes (15)

• Intrauterine fetal growth and wellbeing as assessed by antenatal serial ultrasound scans

  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

  Birth till 4-6 weeks post-delivery

• Other perinatal and neonatal outcomes

  Birth till 4-6 weeks post-delivery

• Fetal (cord) insulinaemia and C-peptide

  At birth

• Maternal glycaemic control

  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).

Study Arms (2)

Intervention (myo-inositol and folic acid supplement)

EXPERIMENTAL

Participants in the intervention arm will receive a total of 4 g/day of myo-inositol and 300 mcg/day of folic acid, divided into two daily doses.

Dietary Supplement: Myo-inositol and folic acid supplement

Control (folic acid supplement)

ACTIVE COMPARATOR

Participants in the control arm will receive a total of 300 mcg/day of folic acid, divided into two daily doses.

Dietary Supplement: Folic acid supplement

Interventions

Myo-inositol and folic acid supplement DIETARY_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.

Intervention (myo-inositol and folic acid supplement)

Folic acid supplement DIETARY_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.

Control (folic acid supplement)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore, 119228, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Birth Weight; Premature Birth; Stillbirth; Perinatal Death

Interventions

Inositol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Death; Death; Pathologic Processes

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Shiao-Yng Chan, MBBChir (UK), FRCOG (UK), PhD

  National University of Singapore, National University Hospital Singapore, Institute for Human Development and Potential (A*STAR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gladys Woon, Bsc

CONTACT

+65 6516 4134; gladys_woon@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel arm, double-blinded, placebo-controlled, randomized controlled trial design in a 1:1 ratio. Pregnant women with T2DM will be randomly assigned to either the intervention group (receiving supplementation of myo-inositol with folic acid) or the control group (receiving supplementation with folic acid only). Randomization will be stratified by ethnicity to ensure a balanced allocation between arms.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: November 21, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: December 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)