Actively Recruiting

Phase Not Applicable
Age: 21Years - 45Years
FEMALE
NCT07241221

Antenatal Myo-inositol Supplementation in Pre-existing Diabetes

Led by National University Hospital, Singapore · Updated on 2025-12-09

182

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

Sponsors

N

National University Hospital, Singapore

Lead Sponsor

N

National University of Singapore

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Antenatal Myo-inositol Supplementation in Pre-existing Diabetes

Who Can Participate

Age: 21Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 21 years to 45 years old at the time of recruitment
  • Ongoing, viable, singleton intrauterine pregnancy
  • Between 12+0 days and 16+6 days weeks' gestation at recruitment
  • Diagnosed with Type 2 Diabetes Mellitus by documented 75g Oral Glucose Tolerance Test showing fasting glucose >7 mmol/L or 2-hour glucose >11.1 mmol/L, or HbA1C >6.5%, prior to pregnancy or during first 16 weeks of 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
Not Eligible

You will not qualify if you...

  • Known or suspected fetal aneuploidy or genetic/structural anomaly
  • Severe allergy to food items requiring carriage of an Epipen at all times

AI-Screening

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Trial Site Locations

Total: 1 location

1

National University Hospital

Singapore, Singapore, Singapore, 119228

Actively Recruiting

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Research Team

G

Gladys Woon, Bsc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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