Идёт набор NCT07685015

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

Без фазы С лечением Gestational Diabetes Mellitus (GDM)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Myo-inositol 2 g + Folic acid 200 µg, Folic acid 200 µg, Insulin therapy, Nutrition therapy.
Кому может быть актуально: Состояния в реестре: Gestational Diabetes Mellitus (GDM). Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австрия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Impact of Myo-Inositol Supplementation on Glycemic Control and Oxidative Stress in Women With Gestational Diabetes Mellitus: A Randomized, Open-Label Pilot Study

Обзор

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.

Вмешательства

Пищевая добавка 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.
Пищевая добавка 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.
Препарат Insulin therapy
Women with GDM who maintain their blood glucose levels with insulin therapy.
Поведенческое Nutrition therapy
Women with GDM who maintain their blood sugar levels with nutritional therapy.

Первичные конечные точки

Time in Range [Срок оценки: 10 days at baseline (24.-28. gestational week), 10 days into gestational week 33, 10 days into gestational week 36/37]

Вторичные конечные точки (12)

Fasting glucose [Срок оценки: 24.-28. gestational week, 33. gestational week, 37. gestational week]
Fasting insulin [Срок оценки: 24.-28. gestational week, 33. gestational week, 37. gestational week]
HOMA-IR [Срок оценки: 24.-28. gestational week, 33. gestational week, 37. gestational week]
HbA1c [Срок оценки: 24.-28. gestational week, 33. gestational week, 37. gestational week]
Insulin doses [Срок оценки: from day 1 until delivery]
Pre Pregnancy BMI [Срок оценки: before pregnancy]
Height in meters [Срок оценки: at baseline]
Weight in kilograms [Срок оценки: 24.-28. gestational week, 33. gestational week, 37. gestational week]
Blood Pressure [Срок оценки: 24.-28. gestational week, 33. gestational week, 37. gestational week]
C-Section (maternal and fetal outcomes) [Срок оценки: at delivery]
Hypoglycemia of the child (maternal and fetal outcomes) [Срок оценки: at delivery]
Preterm birth (maternal and fetal outcomes) [Срок оценки: at delivery]

Критерии участия

Критерии включения

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