The Effect of High-morning-carbohydrate Intake Versus Low-morning-carbohydrate Intake on Glycemic Variability Measured by Continuous Glucose Monitoring in GDM Patients - a Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- mean amplitude of glucose excursions (MAGE)
研究概览
简要总结
This study aims to investigate whether high-morning carbohydrate intake (HMK) compared with low-morning carbohydrate intake (LMK) affects glycemic variability in GDM patients based on Continuous glucose monitoring (CGM).
High carbohydrate morning intake is expected to reduce hyperglycemic episodes and stabilize blood glucose compared with low morning carbohydrate intake.
详细描述
Background:
Women with GDM have an increased risk of macrosomia, cesarean section, birth defects and long term complications such as an increased risk, in both mother and child, to develop type 2 diabetes.
According to Invitro and invivo studies of type 1 and 2 diabetes, great variations in blood glucose levels caused more complications than constantly elevated glucose levels. This study, therefore, intends to use Continuous glucose monitoring (CGM) for day-to-day monitoring of glycemic variability, including frequency, duration, and magnitude of hyperglycaemic fluctuations.
Carbohydrate is the macronutrient that has the greatest impact on postprandial blood glucose response. Despite this, there is a current lack of evidence of how the carbohydrate intake should be distributed throughout a day.
This study aims to investigate whether high-morning carbohydrate intake (HMK) compared to low-morning carbohydrate intake (LMK) affects glycemic variability in GDM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational diabetes mellitus diagnosed according to current WHO criteria for a 2-hour oral glucose tolerance test (OGTT) > 8.5 mmol/l
- •Non-insulin depending
- •Adult 18+ years
- •Gestational age weeks 30-36 at start of inclusion
排除标准
- •Diagnosed with celiac disease
- •Received bariatric surgery
- •Diagnosed eating disorder
- •Insulin-dependent diabetes at trial start
- •Known with type 2 diabetes before pregnancy
- •Children under 18 years
- •Starting up in insulin during the intervention period
- •Diagnosed with lactose intolerance
- •Goes into labor before the intervention is completed
研究组 & 干预措施
Low-morning-carbohydrate
Low morning intake and high evening intake of carbohydrates. This means a distribution of carbohydrate as follows:
10% morning, 40% lunch, 50% dinner. The overall recommendations for macro- and micronutrient intake for GDM patients will be met.
干预措施: High/low carbohydrate distribution (Behavioral)
High-morning-carbohydrate
High morning intake and low evening intake of carbohydrates.
This means a distribution of carbohydrate as follows:
50% morning, 40% lunch, 10% dinner. The overall recommendations for macro- and micronutrient intake for GDM patients will be met.
干预措施: High/low carbohydrate distribution (Behavioral)
结局指标
主要结局
mean amplitude of glucose excursions (MAGE)
时间窗: 6 days
An index for glycemic variability assessment MAGE is the average variation in amplitude and is calculated as the mean of absolute value differences between adjacent glucose peaks and valleys, where the differences exceed 1 Standard Deviation (SD) from the mean.
次要结局
- MBG(6 days)
- C-peptide(11 days)
- Coefficient of variation(6 days)
- Glucagon-like-peptide 1 (GLP1)(1 hour *2)
- Gastric inhibitory polypeptide (GIP)(1 hour*2)