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

Summary

The purpose of this clinical study is to investigate the potential effects of myo-inositol supplementation on changes in glycemic control parameters, oxidative stress, inflammatory biomarkers, psychometric markers, and body composition in participants with gestational diabetes mellitus (GDM).

The study duration is 3 to 3.5 months, depending on the time of GDM diagnosis. Before the active phase begins, there is a 10-day observation period during which participants' blood glucose levels are monitored using a continuous glucose monitoring device. In the subsequent 12-14-week study phase, participants will receive a supplement based on random group 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 until delivery.

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 per meal. 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 evaluation of 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 target glucose range), three glucose sensor measurements will be performed. At each visit, blood samples will be taken to analyze glycemic control parameters (hemoglobin A1c (HbA1c), fasting glucose, fasting insulin, Homeostasis Model Assessment (HOMA-IR), insulin dosage), oxidative stress markers (total antioxidant capacity, malondialdehyde levels), and inflammatory markers (interleukin-6 (IL-6), C-reactive protein (CRP)). Anthropometric measurements (weight gain, blood pressure, pulse) and body composition (Bioelectrical Impedance Analysis) will also be performed.

Additionally, maternal and fetal birth outcomes will be recorded, including cesarean section rates, fetal gestational weight, preterm birth rates, and neonatal hypoglycemia occurrence. To assess participants' well-being and physical activity, questionnaires will be distributed at the beginning and end of the study.

Conditions

• Gestational Diabetes Mellitus (GDM)

Interventions

DIETARY_SUPPLEMENT

Myo-inositol 2 g + Folic acid 200 µg

This dietary supplement contains 2 g of myo-inositol and 200 µg folic acid per capsule. It should be taken twice a day (à 3 capsules) with fluid intake and a meal.

DIETARY_SUPPLEMENT

Folic acid 200 µg

This dietary supplement contains 200 μg of folic acid per capsule and should also be taken twice a day (à 1 capsule) with adequate fluid intake and a main meal.

DRUG

Insulin therapy

Women with GDM who maintain their blood glucose levels with insulin therapy.

BEHAVIORAL

Nutrition therapy

Women with GDM who maintain their blood sugar levels with nutritional therapy.

Sponsors & Collaborators

• BIOGENA GmbH, Salzburg

  collaborator UNKNOWN

• Medical University of Vienna

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-23

Primary Completion

2027-04-01

Completion

2027-07-01

Countries

• Austria

Study Locations