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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc
- Numero di telefono: +43 1 404 00-60950
- Email: Michael.Leutner@meduniwien.ac.at
Backup dei contatti dello studio
- Nome: Ricarda Rosalia Baron, MSc, Msc
- Numero di telefono: +43 1 404 00-20690
- Email: Ricarda.Baron@meduniwien.ac.at
Luoghi di studio
-
-
State of Vienna
-
Vienna, State of Vienna, Austria, 1090
- Reclutamento
- Medical University of Vienna
-
Contatto:
- Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc
- Numero di telefono: +43 1 404 00-60950
- Email: Michael.Leutner@meduniwien.ac.at
-
Sub-investigatore:
- Ricarda Rosalia Baron, MSc, MSc
-
Vienna, State of Vienna, Austria, 1090
- Reclutamento
- Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna
-
Contatto:
- Ricarda Rosalia Baron Baron, MSc
- Numero di telefono: + 43 40400 20690
- Email: Ricarda.Baron@meduniwien.ac.at
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
Women with GDM who maintain their blood sugar levels with nutritional therapy.
|
|
Sperimentale: 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.
|
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.
Women with GDM who maintain their blood glucose levels with insulin therapy.
|
|
Comparatore attivo: 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.
|
Women with GDM who maintain their blood sugar levels with nutritional therapy.
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.
|
|
Comparatore attivo: 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.
|
Women with GDM who maintain their blood glucose levels with insulin therapy.
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time in Range
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Fasting glucose
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 24.-28. gestational week, 33. gestational week, 37. gestational week
|
HbA1c [%] concentration
|
24.-28. gestational week, 33. gestational week, 37. gestational week
|
|
Insulin doses
Lasso di tempo: from day 1 until delivery
|
insulin units [IU]
|
from day 1 until delivery
|
|
Pre Pregnancy BMI
Lasso di tempo: before pregnancy
|
weight [kg]/height [m]^2
|
before pregnancy
|
|
Height in meters
Lasso di tempo: at baseline
|
height [m]
|
at baseline
|
|
Weight in kilograms
Lasso di tempo: 24.-28. gestational week, 33. gestational week, 37. gestational week
|
weight [kg]
|
24.-28. gestational week, 33. gestational week, 37. gestational week
|
|
Blood Pressure
Lasso di tempo: 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)
Lasso di tempo: at delivery
|
C-Section yes or no
|
at delivery
|
|
Hypoglycemia of the child (maternal and fetal outcomes)
Lasso di tempo: at delivery
|
glucose values of the child [mg/dl]
|
at delivery
|
|
Preterm birth (maternal and fetal outcomes)
Lasso di tempo: at delivery
|
delivery before 37. gestational week yes or no
|
at delivery
|
|
Gestational weight of the child (maternal and fetal outcomes)
Lasso di tempo: at delivery
|
gestational weight of the child [kg]
|
at delivery
|
|
Oxidative stress parameter
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 24.-28. gestational week, 37. gestational week
|
Questionnaire: Pregnancy-related Anxiety score
|
24.-28. gestational week, 37. gestational week
|
|
Psychometric parameter
Lasso di tempo: 24.-28. gestational week, 37. gestational week
|
Questionnaire: Postnatal-Depression score
|
24.-28. gestational week, 37. gestational week
|
|
Psychometric parameter
Lasso di tempo: 24.-28. gestational week, 37. gestational week
|
Questionnaire: Perceived Stress score
|
24.-28. gestational week, 37. gestational week
|
|
Physical Activity parameter
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 24.-28. gestational week, 33. gestational week, 37. gestational week
|
extracellular mass [%]
|
24.-28. gestational week, 33. gestational week, 37. gestational week
|
Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie del sistema endocrino
- Processi patologici
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie metaboliche
- Complicazioni della gravidanza
- Disturbi del metabolismo del glucosio
- Diabete mellito
- Condizioni patologiche, segni e sintomi
- Malattie nutrizionali e metaboliche
- Diabete, gestazionale
- Infiammazione
- Prodotti chimici organici
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Terapie
- Carboidrati
- Discipline e attività comportamentali
- Alcoli
- Pterins
- Pteridine
- Terapie somatiche psichiatriche
- Alcoli di zucchero
- Acido folico
- Inositolo
- Terapia nutrizionale
- Terapia Convulsivante
Altri numeri di identificazione dello studio
- 2469/2024
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .