Gestational Diabetes Mellitus (GDM)
Conditions
Keywords
Gestational Diabetes Mellitus, GDM, Myo-Inositol, Continous Glucose Monitoring, CGM, Oxidative Stress, Inflammation, Glycemic Control, Inositol, MYO, MI, Pregnancy
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.
Interventions
DIETARY_SUPPLEMENTMyo-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.
DIETARY_SUPPLEMENTFolic 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.
DRUGInsulin therapy
Women with GDM who maintain their blood glucose levels with insulin therapy.
BEHAVIORALNutrition therapy
Women with GDM who maintain their blood sugar levels with nutritional therapy.
Sponsors
Medical University of Vienna
BIOGENA GmbH, Salzburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose | 24.-28. gestational week, 33. gestational week, 37. gestational week | fasting glucose \[mg/dl\] concentration |
| Fasting insulin | 24.-28. gestational week, 33. gestational week, 37. gestational week | fasting insulin \[μIU/mL\] concentration |
| HOMA-IR | 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 |
| HbA1c | 24.-28. gestational week, 33. gestational week, 37. gestational week | HbA1c \[%\] concentration |
| Insulin doses | from day 1 until delivery | insulin units \[IU\] |
| Pre Pregnancy BMI | before pregnancy | weight \[kg\]/height \[m\]\^2 |
| Height in meters | at baseline | height \[m\] |
| Weight in kilograms | 24.-28. gestational week, 33. gestational week, 37. gestational week | weight \[kg\] |
| Blood Pressure | 24.-28. gestational week, 33. gestational week, 37. gestational week | blood pressure \[mmHg\] |
| C-Section (maternal and fetal outcomes) | at delivery | C-Section yes or no |
| Hypoglycemia of the child (maternal and fetal outcomes) | at delivery | glucose values of the child \[mg/dl\] |
| Preterm birth (maternal and fetal outcomes) | at delivery | delivery before 37. gestational week yes or no |
| Gestational weight of the child (maternal and fetal outcomes) | at delivery | gestational weight of the child \[kg\] |
| Oxidative stress parameter | 24.-28. gestational week, 33. gestational week, 37. gestational week | total antioxidative capacity \[µmol/l\] |
| Inflammatory parameter | 24.-28. gestational week, 33. gestational week, 37. gestational week | C-reactive protein \[mg/dl\] |
| Psychometric parameter | 24.-28. gestational week, 37. gestational week | Questionnaire: Pregnancy-related Anxiety score * minimum score: 10 * maximum score: 50 |
| Physical Activity parameter | 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 |
| Nutritional log | 24.-28. gestational week, 33. gestational week, 37. gestational week | Food diary for 10 days |
| Bioelectrical Impedance Analysis (BIA) | 24.-28. gestational week, 33. gestational week, 37. gestational week | fat mass \[kg\] |
Countries
Austria
Contacts
CONTACTMichael Priv.Doz. Dr.med.univ. Leutner, PhD MSc
CONTACTRicarda Rosalia Baron, MSc, Msc
Outcome results
None listed