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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
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.
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.
Women with GDM who maintain their blood glucose levels with insulin therapy.
Women with GDM who maintain their blood sugar levels with nutritional therapy.
Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna
Vienna, State of Vienna, Austria
RECRUITINGMedical University of Vienna
Vienna, State of Vienna, Austria
RECRUITINGTime in Range
Time in Range \[%\] measured with continous glucose monitoring
Time frame: 10 days at baseline (24.-28. gestational week), 10 days into gestational week 33, 10 days into gestational week 36/37
Fasting glucose
fasting glucose \[mg/dl\] concentration
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Fasting insulin
fasting insulin \[μIU/mL\] concentration
Time frame: 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
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
HbA1c
HbA1c \[%\] concentration
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Insulin doses
insulin units \[IU\]
Time frame: from day 1 until delivery
Pre Pregnancy BMI
weight \[kg\]/height \[m\]\^2
Time frame: before pregnancy
Height in meters
height \[m\]
Time frame: at baseline
Weight in kilograms
weight \[kg\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Blood Pressure
blood pressure \[mmHg\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
C-Section (maternal and fetal outcomes)
C-Section yes or no
Time frame: at delivery
Hypoglycemia of the child (maternal and fetal outcomes)
glucose values of the child \[mg/dl\]
Time frame: at delivery
Preterm birth (maternal and fetal outcomes)
delivery before 37. gestational week yes or no
Time frame: at delivery
Gestational weight of the child (maternal and fetal outcomes)
gestational weight of the child \[kg\]
Time frame: at delivery
Oxidative stress parameter
total antioxidative capacity \[µmol/l\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Oxidative stress parameter
Malondialdehy status \[µmol/l\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter
C-reactive protein \[mg/dl\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter
interleucin-6 \[pg/ml\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Psychometric parameter
Questionnaire: Pregnancy-related Anxiety score * minimum score: 10 * maximum score: 50
Time frame: 24.-28. gestational week, 37. gestational week
Psychometric parameter
Questionnaire: Postnatal-Depression score * total possible score: 0-30 * higher scores: more depressive symptoms
Time frame: 24.-28. gestational week, 37. gestational week
Psychometric parameter
Questionnaire: Perceived Stress score * minimum raw score: 20 * maximum raw score: 80
Time frame: 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
Time frame: 24.-28. gestational week, 37. gestational week
Nutritional log
Food diary for 10 days
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
fat mass \[kg\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
total body water \[%\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
muscle mass \[kg\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
fat free mass \[%\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
body cell mass \[%\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
extracellular mass \[%\]
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc
CONTACT
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