The Impact of Myo-Inositol on Glycemic Control and Oxidative Stress in Gestational Diabetes Mellitus

The purpose of this clinical study is to investigate the potential effects ofmyo‐inositol supplementation on changes in glycemic control parameters, oxidative stress,inflammatory biomarkers, psychometric markers, and body composition in participants withgestational diabetes mellitus (GDM).The study duration is 3 to 3.5 months, depending on the time of GDM diagnosis. Before theactive phase begins, there is a 10‐day observation period during which participants'blood glucose levels are monitored using a continuous glucose monitoring device. In thesubsequent 12‐14‐week study phase, participants will receive a supplement based on randomgroup assignment. They will be allocated either to an intervention group (myo‐inositol +folic acid) or a control group (folic acid). Both supplements will be taken untildelivery.The intervention group supplement contains 4 g myo‐inositol and 400 μg folic acid(BIOGENA GmbH, Salzburg) and is to be taken twice daily with water ‐ three capsules permeal. The control group supplement contains only 400 μg folic acid (BIOGENA GmbH,Salzburg) and is also taken twice daily, one capsule per meal. As this is a pilot study,both participants and study personnel will be aware of group assignments.Blood glucose measurements will be repeated mid‐study (around the 33rd week of pregnancy)and at the end (37th week of pregnancy) using glucose sensors. To improve the evaluationof glucose measurements, participants will keep dietary logs during these periods.Three study visits are planned, during which the following assessments will be conducted.To determine the primary outcome, "time in range (TIR)" (time spent within the targetglucose range), three glucose sensor measurements will be performed. At each visit, bloodsamples will be taken to analyze glycemic control parameters (hemoglobin A1c (HbA1c),fasting glucose, fasting insulin, Homeostasis Model Assessment (HOMA‐IR), insulindosage), oxidative stress markers (total antioxidant capacity, malondialdehyde levels),and inflammatory markers (interleukin‐6 (IL‐6), C‐reactive protein (CRP)). Anthropometricmeasurements (weight gain, blood pressure, pulse) and body composition (BioelectricalImpedance Analysis) will also be performed.Additionally, maternal and fetal birth outcomes will be recorded, including cesareansection rates, fetal gestational weight, preterm birth rates, and neonatal hypoglycemiaoccurrence. To assess participants' well‐being and physical activity, questionnaires willbe distributed at the beginning and end of the study.