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

2. Juli 2026 aktualisiert von: Michael Leutner, Medical University of Vienna

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Österreich
    • State of Vienna
      • Vienna, State of Vienna, Österreich, 1090
        • Rekrutierung
        • Medical University of Vienna
        • Kontakt:
        • Unterermittler:
          • Ricarda Rosalia Baron, MSc, MSc
      • Vienna, State of Vienna, Österreich, 1090
        • Rekrutierung
        • Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Nahrungsergänzungsmittel: 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.
Verhalten: 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.
Nahrungsergänzungsmittel: 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.
Arzneimittel: Insulin therapy
Women with GDM who maintain their blood glucose levels with insulin therapy.
Aktiver Komparator: 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.
Verhalten: Nutrition therapy
Women with GDM who maintain their blood sugar levels with nutritional therapy.
Nahrungsergänzungsmittel: 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.
Aktiver Komparator: 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.
Arzneimittel: Insulin therapy
Women with GDM who maintain their blood glucose levels with insulin therapy.
Nahrungsergänzungsmittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time in Range
Zeitfenster: 10 days at baseline (24.-28. gestational week), 10 days into gestational week 33, 10 days into gestational week 36/37
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fasting glucose
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
fasting glucose [mg/dl] concentration
24.-28. gestational week, 33. gestational week, 37. gestational week
Fasting insulin
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
fasting insulin [μIU/mL] concentration
24.-28. gestational week, 33. gestational week, 37. gestational week
HOMA-IR
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
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
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
HbA1c [%] concentration
24.-28. gestational week, 33. gestational week, 37. gestational week
Insulin doses
Zeitfenster: from day 1 until delivery
insulin units [IU]
from day 1 until delivery
Pre Pregnancy BMI
Zeitfenster: before pregnancy
weight [kg]/height [m]^2
before pregnancy
Height in meters
Zeitfenster: at baseline
height [m]
at baseline
Weight in kilograms
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
weight [kg]
24.-28. gestational week, 33. gestational week, 37. gestational week
Blood Pressure
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
blood pressure [mmHg]
24.-28. gestational week, 33. gestational week, 37. gestational week
C-Section (maternal and fetal outcomes)
Zeitfenster: at delivery
C-Section yes or no
at delivery
Hypoglycemia of the child (maternal and fetal outcomes)
Zeitfenster: at delivery
glucose values of the child [mg/dl]
at delivery
Preterm birth (maternal and fetal outcomes)
Zeitfenster: at delivery
delivery before 37. gestational week yes or no
at delivery
Gestational weight of the child (maternal and fetal outcomes)
Zeitfenster: at delivery
gestational weight of the child [kg]
at delivery
Oxidative stress parameter
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
total antioxidative capacity [µmol/l]
24.-28. gestational week, 33. gestational week, 37. gestational week
Oxidative stress parameter
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
Malondialdehy status [µmol/l]
24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
C-reactive protein [mg/dl]
24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
interleucin-6 [pg/ml]
24.-28. gestational week, 33. gestational week, 37. gestational week
Psychometric parameter
Zeitfenster: 24.-28. gestational week, 37. gestational week

Questionnaire: Pregnancy-related Anxiety score

  • minimum score: 10
  • maximum score: 50
24.-28. gestational week, 37. gestational week
Psychometric parameter
Zeitfenster: 24.-28. gestational week, 37. gestational week

Questionnaire: Postnatal-Depression score

  • total possible score: 0-30
  • higher scores: more depressive symptoms
24.-28. gestational week, 37. gestational week
Psychometric parameter
Zeitfenster: 24.-28. gestational week, 37. gestational week

Questionnaire: Perceived Stress score

  • minimum raw score: 20
  • maximum raw score: 80
24.-28. gestational week, 37. gestational week
Physical Activity parameter
Zeitfenster: 24.-28. gestational week, 37. gestational week

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
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
Food diary for 10 days
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
fat mass [kg]
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
total body water [%]
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
muscle mass [kg]
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
fat free mass [%]
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
body cell mass [%]
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Zeitfenster: 24.-28. gestational week, 33. gestational week, 37. gestational week
extracellular mass [%]
24.-28. gestational week, 33. gestational week, 37. gestational week

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Medical University of Vienna

Mitarbeiter

BIOGENA GmbH, Salzburg

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. März 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

29. April 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juli 2026

Zuerst gepostet (Tatsächlich)

6. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2469/2024

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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