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| Name | Class |
|---|---|
| BIOGENA GmbH, Salzburg | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Intervention group (nutrition therapy + myo-inositol + folic acid) | Experimental | Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the investigational supplement myo-inositol plus folic acid. |
|
| 2. Intervention group (insulin therapy + myo-inositol + folic acid) | Experimental | 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. |
|
| 3. Control group (nutrition therapy + folic acid) | Active Comparator | Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the supplement folic acid. |
|
| 4. Control group (inuslin therapy + folic acid) | Active Comparator | Women who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the supplement folic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myo-inositol 2 g + Folic acid 200 µg | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc | Contact | +43 1 404 00-60950 | michael.leutner@meduniwien.ac.at | |
| Ricarda Rosalia Baron, MSc, Msc | Contact | +43 1 404 00-20690 | Ricarda.Baron@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna | Recruiting | Vienna | State of Vienna | 1090 | Austria |
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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).
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| Folic acid 200 µg | Dietary Supplement | 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. |
|
| Insulin therapy | Drug | Women with GDM who maintain their blood glucose levels with insulin therapy. |
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| Nutrition therapy | Behavioral | Women with GDM who maintain their blood sugar levels with nutritional therapy. |
|
| 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
| 24.-28. gestational week, 37. gestational week |
| Psychometric parameter | Questionnaire: Postnatal-Depression score
| 24.-28. gestational week, 37. gestational week |
| Psychometric parameter | Questionnaire: Perceived Stress score
| 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 |
| Medical University of Vienna | Recruiting | Vienna | State of Vienna | 1090 | Austria |
|
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| D005492 | Folic Acid |
| D003295 | Convulsive Therapy |
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D013812 | Therapeutics |
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