Type 2 Diabetes (T2D) Clinical Trials

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Antenatal Myo-inositol Supplementation in Pre-existing Diabetes to Promote Normal Neonatal Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Singapore
National University Hospital
RECRUITING
Singapore
Contact Information
Primary
Gladys Woon, Bsc
gladys_woon@nuhs.edu.sg
+65 6516 4134
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 182
Treatments
Experimental: Intervention (myo-inositol and folic acid supplement)
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.
Active_comparator: Control (folic acid supplement)
Participants in the control arm will receive a total of 300 mcg/day of folic acid, divided into two daily doses.
Related Therapeutic Areas
Sponsors
Collaborators: National University of Singapore
Leads: National University Hospital, Singapore

This content was sourced from clinicaltrials.gov