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临床试验/NCT03644238
NCT03644238已完成不适用

The Acute Effect of Physical Activity on Blood Glucose in Pregnant Women

University of Aarhus2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年8月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Blood glucose

研究概览

简要总结

The aim of the project is to investigate the acute effect of exercise on blood glucose after glucose consumption. Thereby we wish to achieve knowledge that can improve prevention and treatment of gestational overweight and gestational diabetes mellitus (GDM). This will prevent serious complications during pregnancy and birth, but also long term complications like type 2 diabetes mellitus (T2DM) for both the mother and the offspring.

15 pregnant participants will perform two Oral Glucose Tolerance Tests (OGTT). One is followed by physical activity and the other is followed by inactivity and will serve as control. Blood glucose will be monitored continuously during the study.

详细描述

Cases: 15 pregnant women recruited at the routine ultrasound scan at gestational week 19 at the Department of Obstetrics and Gynecology, Aarhus University Hospital. Subjects will receive both written and oral information before entering the trial. Subjects with a prepregnancy BMI > 27 and no other risk factors of diabetes will be included in the study. The women will be examined during gestational week 27-30 where the routine Oral Glucose Tolerance Test (OGTT) will take place. The routine OGTT will serve as control.

Intervention: The subjects will perform two OGTT separated by a minimum of two days. One - the regular OGTT will serve as control and the second OGTT will be the intervention. The two days in between will function as a "wash out period" to avoid potential carry over effect. During the OGTT subjects will consume a liquid containing 75g of glucose. The control OGTT will be followed by inactivity. The intervention OGTT will be immediately followed by 20 minutes of exercise on a bicycle ergometer with a fixed intensity.

Study variables: Blood glucose will be monitored continuously using the IPro2 Continous Glucose Monitor (CGM) from Medtronic. A sensor is inserted into interstitial fluid and continuously generates an electrical current proportional to the glucose concentration. A recorder stores the average sensor current every 5 minutes.

In both control and intervention, blood tests will be taken at time 0, 1 and 2 hours after the OGTT. Blood samples will be analyzed for blood glucose, HbA1c, C-peptide and insulin.

Data on demography, family history of diabetes, prepregnancy BMI, gestational weight gain and complications during pregnancy are collected from medical records of the patients and their offspring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
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

入选标准

  • Prepregnancy BMI > 27

排除标准

  • Physical disability that affect movement

研究组 & 干预措施

Control intervention

Other

Oral Glucose Tolerance Test and inactivity.

干预措施: Inactivity (Behavioral)

Experimental intervention

Experimental

Oral Glucose Tolerance Test and physical activity

干预措施: Oral Glucose Tolerance Test (Diagnostic Test)

Experimental intervention

Experimental

Oral Glucose Tolerance Test and physical activity

干预措施: Physical activity (Behavioral)

Control intervention

Other

Oral Glucose Tolerance Test and inactivity.

干预措施: Oral Glucose Tolerance Test (Diagnostic Test)

结局指标

主要结局

Blood glucose

时间窗: Through intervention periods of 2 hours.

Difference in blood glucose between experimental intervention and control intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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