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

2026年7月2日 更新者：Michael Leutner、Medical University of Vienna

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

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 奥地利
    • State of Vienna
      • Vienna、State of Vienna、奥地利、1090
        • 招聘中
        • Medical University of Vienna
        • 接触：
        • 副研究员：
          • Ricarda Rosalia Baron, MSc, MSc
      • Vienna、State of Vienna、奥地利、1090
        • 招聘中
        • Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：1. Intervention group (nutrition therapy + myo-inositol + folic acid)
Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the investigational supplement myo-inositol plus folic acid.
膳食补充剂：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.
行为的：Nutrition therapy
Women with GDM who maintain their blood sugar levels with nutritional therapy.
实验性的：2. Intervention group (insulin therapy + myo-inositol + folic acid)
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.
膳食补充剂：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.
药品：Insulin therapy
Women with GDM who maintain their blood glucose levels with insulin therapy.
有源比较器：3. Control group (nutrition therapy + folic acid)
Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the supplement folic acid.
行为的：Nutrition therapy
Women with GDM who maintain their blood sugar levels with nutritional therapy.
膳食补充剂：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.
有源比较器：4. Control group (inuslin therapy + folic acid)
Women who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the supplement folic acid.
药品：Insulin therapy
Women with GDM who maintain their blood glucose levels with insulin therapy.
膳食补充剂：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time in Range
大体时间：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
10 days at baseline (24.-28. gestational week), 10 days into gestational week 33, 10 days into gestational week 36/37

次要结果测量

结果测量
措施说明
大体时间
Fasting glucose
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
fasting glucose [mg/dl] concentration
24.-28. gestational week, 33. gestational week, 37. gestational week
Fasting insulin
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
fasting insulin [μIU/mL] concentration
24.-28. gestational week, 33. gestational week, 37. gestational week
HOMA-IR
大体时间：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
24.-28. gestational week, 33. gestational week, 37. gestational week
HbA1c
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
HbA1c [%] concentration
24.-28. gestational week, 33. gestational week, 37. gestational week
Insulin doses
大体时间：from day 1 until delivery
insulin units [IU]
from day 1 until delivery
Pre Pregnancy BMI
大体时间：before pregnancy
weight [kg]/height [m]^2
before pregnancy
Height in meters
大体时间：at baseline
height [m]
at baseline
Weight in kilograms
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
weight [kg]
24.-28. gestational week, 33. gestational week, 37. gestational week
Blood Pressure
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
blood pressure [mmHg]
24.-28. gestational week, 33. gestational week, 37. gestational week
C-Section (maternal and fetal outcomes)
大体时间：at delivery
C-Section yes or no
at delivery
Hypoglycemia of the child (maternal and fetal outcomes)
大体时间：at delivery
glucose values of the child [mg/dl]
at delivery
Preterm birth (maternal and fetal outcomes)
大体时间：at delivery
delivery before 37. gestational week yes or no
at delivery
Gestational weight of the child (maternal and fetal outcomes)
大体时间：at delivery
gestational weight of the child [kg]
at delivery
Oxidative stress parameter
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
total antioxidative capacity [µmol/l]
24.-28. gestational week, 33. gestational week, 37. gestational week
Oxidative stress parameter
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
Malondialdehy status [µmol/l]
24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
C-reactive protein [mg/dl]
24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
interleucin-6 [pg/ml]
24.-28. gestational week, 33. gestational week, 37. gestational week
Psychometric parameter
大体时间：24.-28. gestational week, 37. gestational week

Questionnaire: Pregnancy-related Anxiety score

  • minimum score: 10
  • maximum score: 50
24.-28. gestational week, 37. gestational week
Psychometric parameter
大体时间：24.-28. gestational week, 37. gestational week

Questionnaire: Postnatal-Depression score

  • total possible score: 0-30
  • higher scores: more depressive symptoms
24.-28. gestational week, 37. gestational week
Psychometric parameter
大体时间：24.-28. gestational week, 37. gestational week

Questionnaire: Perceived Stress score

  • minimum raw score: 20
  • maximum raw score: 80
24.-28. gestational week, 37. gestational week
Physical Activity parameter
大体时间：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
24.-28. gestational week, 37. gestational week
Nutritional log
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
Food diary for 10 days
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
fat mass [kg]
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
total body water [%]
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
muscle mass [kg]
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
fat free mass [%]
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
body cell mass [%]
24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
大体时间：24.-28. gestational week, 33. gestational week, 37. gestational week
extracellular mass [%]
24.-28. gestational week, 33. gestational week, 37. gestational week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Medical University of Vienna

合作者

BIOGENA GmbH, Salzburg

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月23日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2025年4月29日

首先提交符合 QC 标准的

2026年7月2日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月2日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2469/2024

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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