Evaluation of Exercise, in Addition to Diet, in Women With Gestational Diabetes
2017年6月1日 更新者：Michel Boulvain、University Hospital, Geneva
The main objective is to evaluate the effect of therapeutic exercise program on blood glucose regulation in women with gestational diabetes mellitus (GDM) who are assigned to diet-and-exercise, compared to diet only (usual treatment).
The primary outcome is the need for insulin treatment in the two groups.
研究概览
详细说明
In women with gestational diabetes, light to moderate daily physical activity may a useful therapeutic approach to improve the control of glycaemia and decrease the need for prescription of insulin. Increased physical activity in pregnant women with gestational diabetes is expected to decrease the mother and child morbidity associated with gestational diabetes, but also to improve the general health status of the mother and the child.
The objectives of this randomized trial are:
- To evaluate the effect of therapeutic exercise program on blood glucose regulation in women with GDM who are assigned to diet-and-exercise protocol.
- To demonstrate the feasibility of the therapeutic exercise treatment and the possibility of using the exercise program as an optional therapeutic approach for women with GDM.
研究类型
介入性
注册 (实际的)
109
阶段
- 不适用
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
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- gestational diabetes, based on the criteria of Coustan-Carpenter, then on the International Association Diabetes Pregnancy Study Groups (IADPSG )
Exclusion Criteria:
- pre-existing diabetes
- twins
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：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：Exercise + diet
Exercise intervention: During the first session a standardized exercise prescription will be discussed with the participant. The exercise program will be of a moderate intensity, at less than 140 heart beats/min (which corresponds to 60% of the calculated maximum heart rate (HRmax) or 50% maximum oxygen volume (VO2max) ). A session of 30 to 60 minutes/week will be organised.
This is in addition to the diet (see below, control group) |
Once per week, participants will be enrolled in supervised group exercise intervention.
They will be encouraged in walking 45 minutes per day
|
|
无干预：Diet only
Participants will receive diet counselling according to their characteristics.
The usual recommendation is to have a fractioned normocaloric diet (unless the dietician identify a grossly hypercaloric diet), with low fat and increase in fibers content.
|
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 |
|---|---|---|
|
Prescription of insulin during the follow-up
大体时间：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery, usually 38 to 41 weeks of gestation). It is impossible in our context to give a specific time point.
|
The primary outcome will include any amount (dosage) of insulin and any frequency of injection.
Prescription of insulin is considered when glycaemia is above 5.3 mmol/L fasting and/or above 8.0 at 1 hour after the meal.
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery, usually 38 to 41 weeks of gestation). It is impossible in our context to give a specific time point.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Control of glycemia
大体时间：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
4 times per day, participants will check their blood sugar level.
The investigators will record these blood sugar levels and consider as normal if below 5.3 mmol/L fasting and below 8.0 at 1 hour after the meal.
Suboptimal glycemic control will be defined as 2 or more glycemia above these target values; good control will be defined as less than 2 values above the thresholds.
The variable "good glycemic control" will be coded "yes" if the above criteria (<2 abnormal values) are met, and "no" otherwise (>=2 abnormal values)
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Compliance with the exercise (in the exercise group only)
大体时间：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
Satisfactory compliance will be defined as walking at least 5000 steps/day 5 days a week and attending at 50% or more of the weekly supervised exercise program.
The variable "compliance" will be coded "yes" if both the above criteria are met, and "no" otherwise
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Timing of insulin treatment
大体时间：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
To better understand the effect of the intervention on the primary outcome, prescription of insulin), the investigators will compare between groups: Time between randomization and insulin prescription (days) |
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Gestational age at start of insulin treatment
大体时间：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
the investigators will compare between groups: Gestational age at start of insulin treatment (weeks) (mean ± SD)
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Dosage of long-acting insulin
大体时间：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
Maximal dose of long-acting insulin per day (mean ± SD)
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Dosage of short-acting insulin
大体时间：usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
Maximal dose of short-acting insulin per day (mean ± SD)
|
usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
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。
调查人员
- 首席研究员：Michel Boulvain、Hôpitaux Universitaires de Genève
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)
2008年2月21日
初级完成 (实际的)
2013年4月25日
研究完成 (实际的)
2013年6月19日
研究注册日期
首次提交
2017年1月24日
首先提交符合 QC 标准的
2017年6月1日
首次发布 (实际的)
2017年6月2日
研究记录更新
最后更新发布 (实际的)
2017年6月2日
上次提交的符合 QC 标准的更新
2017年6月1日
最后验证
2017年6月1日
更多信息
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.
Exercise的临床试验
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的