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

NCT07685015 | Recruiting

• 1 other identifier: 2469/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Gestational Diabetes Mellitus; GDM; Myo-Inositol; Continous Glucose Monitoring; CGM; Oxidative Stress; Inflammation; Glycemic Control; Inositol; MYO; MI; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Time in Range

  Time in Range \[%\] measured with continous glucose monitoring

  10 days at baseline (24.-28. gestational week), 10 days into gestational week 33, 10 days into gestational week 36/37

Secondary Outcomes (28)

• Fasting glucose

  24.-28. gestational week, 33. gestational week, 37. gestational week

• Fasting insulin

  24.-28. gestational week, 33. gestational week, 37. gestational week

• HOMA-IR

  24.-28. gestational week, 33. gestational week, 37. gestational week

• HbA1c

  24.-28. gestational week, 33. gestational week, 37. gestational week

• Insulin doses

  from day 1 until delivery

Study Arms (4)

1. Intervention group (nutrition therapy + myo-inositol + folic acid)

EXPERIMENTAL

Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the investigational supplement myo-inositol plus folic acid.

Dietary Supplement: Myo-inositol 2 g + Folic acid 200 µg; Behavioral: Nutrition therapy

2. Intervention group (insulin therapy + myo-inositol + folic acid)

EXPERIMENTAL

Women who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the investigational supplement myo-inositol plus folic acid.

Dietary Supplement: Myo-inositol 2 g + Folic acid 200 µg; Drug: Insulin therapy

3. Control group (nutrition therapy + folic acid)

ACTIVE COMPARATOR

Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the supplement folic acid.

Dietary Supplement: Folic acid 200 µg; Behavioral: Nutrition therapy

4. Control group (inuslin therapy + folic acid)

ACTIVE COMPARATOR

Women who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the supplement folic acid.

Dietary Supplement: Folic acid 200 µg; Drug: Insulin therapy

Interventions

Myo-inositol 2 g + Folic acid 200 µg DIETARY_SUPPLEMENT

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.

1. Intervention group (nutrition therapy + myo-inositol + folic acid); 2. Intervention group (insulin therapy + myo-inositol + folic acid)

Folic acid 200 µg DIETARY_SUPPLEMENT

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.

3. Control group (nutrition therapy + folic acid); 4. Control group (inuslin therapy + folic acid)

Insulin therapy DRUG

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

2. Intervention group (insulin therapy + myo-inositol + folic acid); 4. Control group (inuslin therapy + folic acid)

Nutrition therapy BEHAVIORAL

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

1. Intervention group (nutrition therapy + myo-inositol + folic acid); 3. Control group (nutrition therapy + folic acid)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• BIOGENA GmbH, Salzburg: collaborator

Study Sites (2)

Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

RECRUITING

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Inflammation

Interventions

Inositol; Folic Acid; Convulsive Therapy; Nutrition Therapy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Therapeutics

Central Study Contacts

Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc

CONTACT

+43 1 404 00-60950; michael.leutner@meduniwien.ac.at

Ricarda Rosalia Baron, MSc, Msc

CONTACT

+43 1 404 00-20690; Ricarda.Baron@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.Doz. Dr.med.univ.

Model Details: The study is designed as a single-center, open-label, randomized, controlled pilot study. The investigators aim to enroll 40 women with GDM, randomly allocated to one of the 4 groups. The interventions groups are divided in group 1 (nutrition therapy + myo-inositol + folic acid) and group 2 (insulin therapy + myo-inositol + folic acid). The control groups are separated in group 3 (nutrition therapy + folic acid) and group 4 (insulin therapy + folic acid).

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: July 6, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)