Myo-Inositol for Glycemic Control in Gestational Diabetes
Official title: The Impact of Myo-Inositol Supplementation on Glycemic Control and Oxidative Stress in Women With Gestational Diabetes Mellitus: A Randomized, Open-Label Pilot Study
Run by Medical University of Vienna · NCT07685015 · Data updated 2026-11-12
This study tests whether taking myo-inositol with folic acid can improve blood sugar control and reduce inflammation in pregnant people with gestational diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 2 sites (Vienna, State of Vienna and 1 other locations) |
| Status | Recruiting |
| Started | March 23, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07685015 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Eligible participants are pregnant individuals aged 18–45 with a GDM diagnosis, meeting at least one HAPO criterion, carrying a single fetus, and without exclusions such as pre-existing diabetes or high BMI (>35).
✕Probably not a fit
Individuals with pre-existing diabetes types, certain chronic conditions, or allergies to study supplements may not experience benefit and could be affected by the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this interventional study, pregnant participants diagnosed with gestational diabetes will first undergo a 10-day continuous glucose monitoring period to establish baseline glycemic patterns. Participants are then randomized to receive either myo-inositol plus folic acid or folic acid alone for about 12 to 14 weeks, continuing until delivery. The primary focus is on glycemic control, with secondary assessments of oxidative stress, inflammatory biomarkers, psychometric markers, and body composition. All participants receive standard care alongside the assigned supplement, under supervision at the Medical University of Vienna and affiliated centers.
Why it matters
Potential benefit: If successful, the intervention could offer an accessible approach to improve glucose management and related metabolic parameters in GDM.
How similar studies have gone: Previous research in related areas has shown potential benefits of myo-inositol in glucose regulation during pregnancy, but results in GDM are variable and area remains under active study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * GDM diagnosis * at least one of the HAPO-Study criteria: 2h-oGTT → \>153 mg/dl, 1h-oGGT → \>180 mg/dl, fasting plasma glucose \> 92 mg/dl * age between 18-45 * single pregnancy Exclusion Criteria: * T2DM * T1DM * Maturity Onset Diabetes of the Young (MODY) * Latent Autoimmune Diabetes in Adults (LADA) * pre pregnancy BMI \>35 * oral antidiabetic drugs * pre-existing renal disease * heart disease and other chronic medical disorders * allergies to any ingredients contained in the dietary supplements
Where it's running
-
Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna
Vienna, State of Vienna, Austria Recruiting -
Medical University of Vienna
Vienna, State of Vienna, Austria Recruiting
Study contacts
- Study coordinator: Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc
- Email: michael.leutner@meduniwien.ac.at
- Phone: +43 1 404 00-60950
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.