The Impact of Myo-Inositol Supplementation on Glycemic Control and Oxidative Stress in Women With Gestational Diabetes Mellitus: A Randomized, Open-Label Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Time in Range
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Time in Range
时间窗: 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
次要结局
- Fasting glucose(24.-28. gestational week, 33. gestational week, 37. gestational week)
- Fasting insulin(24.-28. gestational week, 33. gestational week, 37. gestational week)
- HOMA-IR(24.-28. gestational week, 33. gestational week, 37. gestational week)
- HbA1c(24.-28. gestational week, 33. gestational week, 37. gestational week)
- Insulin doses(from day 1 until delivery)
- Pre Pregnancy BMI(before pregnancy)
- Height in meters(at baseline)
- Weight in kilograms(24.-28. gestational week, 33. gestational week, 37. gestational week)
- Blood Pressure(24.-28. gestational week, 33. gestational week, 37. gestational week)
- C-Section (maternal and fetal outcomes)(at delivery)
- Hypoglycemia of the child (maternal and fetal outcomes)(at delivery)
- Preterm birth (maternal and fetal outcomes)(at delivery)
- Gestational weight of the child (maternal and fetal outcomes)(at delivery)
- Oxidative stress parameter(24.-28. gestational week, 33. gestational week, 37. gestational week)
- Inflammatory parameter(24.-28. gestational week, 33. gestational week, 37. gestational week)
- Psychometric parameter(24.-28. gestational week, 37. gestational week)
- Physical Activity parameter(24.-28. gestational week, 37. gestational week)
- Nutritional log(24.-28. gestational week, 33. gestational week, 37. gestational week)
- Bioelectrical Impedance Analysis (BIA)(24.-28. gestational week, 33. gestational week, 37. gestational week)
研究者
Michael Leutner
Priv.Doz. Dr.med.univ.
Medical University of Vienna