Lifestyle Control of Postprandial Hyperglycemia
2017年8月1日 更新者：Jonathan Little、University of British Columbia
Low-carbohydrate Diet, With or Without Exercise, for Improving Postprandial Glucose Control and Vascular Function in Type 2 Diabetes and Prediabetes.
Large spikes in blood glucose experienced after meals in people with type 2 diabetes are known to damage blood vessels.
Low carbohydrate high fat diets and exercise can improve blood glucose control in people with type 2 diabetes but it is unclear how these two strategies interact to affect blood vessel function and inflammation.
We will examine how following a short-term low carbohydrate high fat diet (4 days) with or without post-meal walking impacts markers of blood vessel function and inflammation.
We will also examine how a single low carbohydrate high fat meal, with or without post-meal walking, impacts blood glucose control and blood vessel function.
Findings will help determine the best lifestyle approach for improving cardiovascular health in type 2 diabetes.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
16
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。
学习地点
-
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British Columbia
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Kelowna、British Columbia、加拿大、V1V 1V7
- University of British Columbia, Okanagan.
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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
40年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosed with type 2 diabetes (at least 6 months ago)
- Aged 40-75
- Engaging in 2 or less moderate-to-vigorous exercise bouts per week in the last 3 months
- Ability to understand and communicate in English to interact with the personal trainer
Exclusion Criteria:
- Diagnosed coronary artery disease
- Any contraindications to exercise (e.g., musculoskeletal injury)
- Prior history of cardio- or cerebrovascular disease or myocardial infarction
- Hypertension that is not controlled by medication (systolic blood pressure (BP) >160 mmHg and/or diastolic BP >99 mmHg)
- Change in diabetes medications in the previous 6 months
- Diagnosed with peripheral neuropathy
- Taking exogenous insulin
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：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：High-carbohydrate diet
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Participants will engage in 4 days of high-carbohydrate low fat diet as recommended by the Canadian Diabetes Association.
The macronutrients content will go as follow: 55% carbohydrate, 25% protein and 20% fat.
Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet.
Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
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实验性的：Low-carbohydrate diet
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Participants will engage in 4 days of low-carbohydrate high-fat diet.
The macronutrients content will go as follow: 10% carbohydrate, 25% protein and 65% fat.
Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet.
Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
|
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实验性的：Low-carbohydrate diet with post-meal walking
|
Participants will engage in 4 days of low-carbohydrate high-fat diet.
The macronutrients content will go as follow: 10% carbohydrate, 25% protein and 65% fat.
Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet.
Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
Participants will follow the same diet as in the low-carbohydrate diet arm but also perform 15 minutes of walking beginning ~15 minutes after breakfast, lunch and dinner.
Approximately 70 kcal (individualized) will be added to main meals to account for exercise energy expenditure.
Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Difference in glycemic control assessed by continuous glucose monitoring in low-carbohydrate, low-carbohydrate plus post-meal walking, and high-carbohydrate low-fat arm.
大体时间：4-day average glucose levels assessed in each arm.
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4-day average glucose levels assessed in each arm.
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change from baseline in circulating inflammatory cytokines after 4 days of intervention.
大体时间：Fasting measurements taken on day 1 and day 5.
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Fasting measurements taken on day 1 and day 5.
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Change from baseline in toll-like receptors 2 and 4 expression on white blood cells after 4 days of intervention.
大体时间：Fasting measurements taken on day 1 and day 5.
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Fasting measurements taken on day 1 and day 5.
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Change from baseline in flow mediated dilation of brachial artery after 4 days of intervention.
大体时间：Fasting measurements taken on day 1 and day 5.
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Fasting measurements taken on day 1 and day 5.
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Change from baseline in flow-mediated dilation after single breakfast meal on day 1 of the intervention
大体时间：Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm
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Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm
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Change from baseline in plasma glucose after single breakfast meal on day 1 of the intervention
大体时间：Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm
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Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm
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Change from baseline in body weight after a single meal and 4 days of intervention.
大体时间：Fasting measures on day 1 and day 5.
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Fasting measures on day 1 and day 5.
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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。
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
2015年11月1日
初级完成 (实际的)
2017年6月1日
研究完成 (实际的)
2017年6月1日
研究注册日期
首次提交
2016年2月11日
首先提交符合 QC 标准的
2016年2月11日
首次发布 (估计)
2016年2月17日
研究记录更新
最后更新发布 (实际的)
2017年8月3日
上次提交的符合 QC 标准的更新
2017年8月1日
最后验证
2017年8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.