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

The Impact of Myo-Inositol Supplementation on Glycemic Control and Oxidative Stress in Women With Gestational Diabetes Mellitus: A Randomized, Open-Label Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus (GDM)
• Intervention / Treatment: Dietary supplement: Myo-inositol 2 g + Folic acid 200 µg; Behavioral: Nutrition therapy; Drug: Insulin therapy; Dietary supplement: Folic acid 200 µg

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc; Phone Number: +43 1 404 00-60950; Email: Michael.Leutner@meduniwien.ac.at
• Study Contact Backup: Name: Ricarda Rosalia Baron, MSc, Msc; Phone Number: +43 1 404 00-20690; Email: Ricarda.Baron@meduniwien.ac.at

Study Locations

• Austria
  • State of Vienna
    • Vienna, State of Vienna, Austria, 1090
      • Recruiting
      • Medical University of Vienna
      • Contact: Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc; Phone Number: +43 1 404 00-60950; Email: Michael.Leutner@meduniwien.ac.at
      • Sub-Investigator: Ricarda Rosalia Baron, MSc, MSc
    • Vienna, State of Vienna, Austria, 1090
      • Recruiting
      • Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna
      • Contact: Ricarda Rosalia Baron Baron, MSc; Phone Number: + 43 40400 20690; Email: Ricarda.Baron@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. Intervention group (nutrition therapy + myo-inositol + folic acid); 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; 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.; Behavioral: Nutrition therapy; Women with GDM who maintain their blood sugar levels with nutritional therapy.
Experimental: 2. Intervention group (insulin therapy + myo-inositol + folic acid); 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; 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.; Drug: Insulin therapy; Women with GDM who maintain their blood glucose levels with insulin therapy.
Active Comparator: 3. Control group (nutrition therapy + folic acid); Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the supplement folic acid.	Behavioral: Nutrition therapy; Women with GDM who maintain their blood sugar levels with nutritional therapy.; 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.
Active Comparator: 4. Control group (inuslin therapy + folic acid); Women who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the supplement folic acid.	Drug: Insulin therapy; Women with GDM who maintain their blood glucose levels with insulin therapy.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	fasting glucose [mg/dl] concentration	24.-28. gestational week, 33. gestational week, 37. gestational week
Fasting insulin	fasting insulin [μIU/mL] concentration	24.-28. gestational week, 33. gestational week, 37. gestational week
HOMA-IR	HOMA-IR calculated as fasting insulin level (micro-units per milliliter) multiplied by the fasting blood glucose level (milligrams per deciliter), dividing the result by 405	24.-28. gestational week, 33. gestational week, 37. gestational week
HbA1c	HbA1c [%] concentration	24.-28. gestational week, 33. gestational week, 37. gestational week
Insulin doses	insulin units [IU]	from day 1 until delivery
Pre Pregnancy BMI	weight [kg]/height [m]^2	before pregnancy
Height in meters	height [m]	at baseline
Weight in kilograms	weight [kg]	24.-28. gestational week, 33. gestational week, 37. gestational week
Blood Pressure	blood pressure [mmHg]	24.-28. gestational week, 33. gestational week, 37. gestational week
C-Section (maternal and fetal outcomes)	C-Section yes or no	at delivery
Hypoglycemia of the child (maternal and fetal outcomes)	glucose values of the child [mg/dl]	at delivery
Preterm birth (maternal and fetal outcomes)	delivery before 37. gestational week yes or no	at delivery
Gestational weight of the child (maternal and fetal outcomes)	gestational weight of the child [kg]	at delivery
Oxidative stress parameter	total antioxidative capacity [µmol/l]	24.-28. gestational week, 33. gestational week, 37. gestational week
Oxidative stress parameter	Malondialdehy status [µmol/l]	24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter	C-reactive protein [mg/dl]	24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter	interleucin-6 [pg/ml]	24.-28. gestational week, 33. gestational week, 37. gestational week
Psychometric parameter	Questionnaire: Pregnancy-related Anxiety score; minimum score: 10; maximum score: 50	24.-28. gestational week, 37. gestational week
Psychometric parameter	Questionnaire: Postnatal-Depression score; total possible score: 0-30; higher scores: more depressive symptoms	24.-28. gestational week, 37. gestational week
Psychometric parameter	Questionnaire: Perceived Stress score; minimum raw score: 20; maximum raw score: 80	24.-28. gestational week, 37. gestational week
Physical Activity parameter	Questionnaire: Physical Activity score [MET] - average daily energy expenditure by calculating the metabolic equivalents (METs) for each activity	24.-28. gestational week, 37. gestational week
Nutritional log	Food diary for 10 days	24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)	fat mass [kg]	24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)	total body water [%]	24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)	muscle mass [kg]	24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)	fat free mass [%]	24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)	body cell mass [%]	24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)	extracellular mass [%]	24.-28. gestational week, 33. gestational week, 37. gestational week

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: BIOGENA GmbH, Salzburg

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 29, 2025
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Pregnancy; Oxidative Stress; CGM; GDM; MI; Glycemic Control; Continous Glucose Monitoring; Inositol; Gestational Diabetes Mellitus; Myo-Inositol; MYO
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes, Gestational; Inflammation; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Carbohydrates; Behavioral Disciplines and Activities; Alcohols; Pterins; Pteridines; Psychiatric Somatic Therapies; Sugar Alcohols; Folic Acid; Inositol; Nutrition Therapy; Convulsive Therapy
• Other Study ID Numbers: 2469/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No