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SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2 (SIT LESS 2)

2016年3月15日 更新者:Maastricht University Medical Center

Introduction: Changes in lifestyle are responsible for an important part of the type 2 diabetes epidemic of the last decennia. Current guidelines for physical activity focus mainly on high energy expenditure advising 30 minutes per day moderate to vigorous physical activity (most often physical exercise). Recent studies suggest that sitting has negative metabolic effects independent of the time spent exercising (Duvivier et al. PLOS ONE 2013).

Low intensity physical activity (LIPA) -such as walking and standing- has been suggested to be an alternative to decrease the hyperglycaemic effect of sitting. Compared to exercise, LIPA might be a more feasible strategy. But, it remains to be determined whether reducing sitting time by replacing it by LIPA, results in lower 24 hour blood glucose levels and less blood glucose fluctuations (glycaemic variability) in type 2 diabetes patients and whether these effects are independent of the increase in energy expenditure

Methods: The study population will involve 19 people with type 2 diabetes (BMI: 25-35 kg/m2) who perform no, or only little, exercise and who are treated with diet only or with oral blood glucose lowering medication. They will perform three regimes of each four days: 1) a sitting regime, 2) an exercise regime and a 3) sit less regime. Daily energy expenditure of the exercise regime will be identical to that of the sit less regime. Sitting, walking and standing will be objectively measured by a 24 hour physical activity monitor. The energy spent during exercise will be standardised and quantified by using a bicycle ergometer; energy intake will be standardised as well. During each regime blood glucose will be measured with a 24 hour continuous glucose sensor.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

19

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

    • Limburg
      • Maastricht、Limburg、荷兰、6200 MD
        • Human Movement Science, Maastricht University

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Signed informed consent
  • Men and women: 40-75 years old
  • Diabetes mellitus type 2, developed after the age of 40 years old
  • Treatment with diet or oral blood glucose lowering medication (metformin and/or SU-derivatives and/or DPP-IV inhibitors)
  • HbA1c: < 10%
  • BMI: 25.0 - 35.0 kg/m2
  • Maximum 2.5 hours of MVPA per week (during last 3 months)
  • Internet availability on a daily basis

Exclusion Criteria:

  • Pregnancy or intention of becoming pregnant
  • Alcohol use: > 2 units per day (during the last 3 months)
  • Experimental drug use (during the last 3 months)
  • Use of insulin, corticosteroids, vitamin K antagonists and immunosuppressive drugs in the last 3 months
  • Triglyceride level > 10.0 mmol/L
  • Fasting plasma glucose level > 10 mmol/L
  • Heart failure NYHA 3 or higher
  • Angina pectoris or signs of cardiac ischemia during exercise testing
  • COPD Gold 3 or higher
  • Glomerular filtration rate (GFR) < 30 ml/min
  • Diagnosis of active cancer (not cancer in the past that is cured)
  • Diabetes mellitus type 1
  • Intermittent claudication with a walking distance < 500 meter
  • Not able to cycle for ± 45 minutes, as judged from the incremental exhaustive exercise bicycle-ergometer test at Visit 1
  • Based on historical information not able to walk for 3 hours per day and stand for 4 hours per day
  • Mental or physical disability which makes physical activity not possible
  • Participation in a clinical trial with medication use (in the last 3 months)
  • Severe loss of vision
  • Active foot ulcer or venous leg ulcer

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:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Sitting regime
The subjects will follow the sitting regime during four days. Each day: 14 hours sitting, 1 hour walking and 1 hour standing for daily care and 8 hours sleeping or lying.
实验性的:Sit Less regime
Subjects will follow the sit less regime during four days. Each day will consist of 3 hours walking, 4 hours standing, 9 hours sitting and 8 hours sleeping or lying. The additional 2 hours of walking and 3 hours of standing, compared to the sitting regime, will be done in a minimum of four bouts with a time interval of > 1 hour. The subjects will be instructed to walk on a slow pace. i.e. 2-3 km/h, which is comparable to walking during shopping, walking to the office etc.
实验性的:Exercise regime
Subjects will follow the exercise regime during four days. Each day will consist of 13 hours and 15 minutes sitting, ± 45 minutes supervised cycling on an ergometer, 1 hour walking and 1 hour standing for daily care and 8 hours sleeping or lying.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Mean 24 hour glucose concentration
大体时间:during the last 24 hours of an activity regime
during the last 24 hours of an activity regime

次要结果测量

结果测量
措施说明
大体时间
Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L)
大体时间:during the last 24 hours of an activity regime
during the last 24 hours of an activity regime
Mean 24 hour glucose concentration
大体时间:during a whole activity regime
during a whole activity regime
Total duration of hyperglycaemia (glucose > 10 mmol/L)
大体时间:during a whole activity regime
during a whole activity regime
Area under the curve of hyperglycaemia (glucose > 10 mmol/L)
大体时间:during the last 24 hours of an activity regime
during the last 24 hours of an activity regime
Glucose variability measured as SD divided by mean
大体时间:the last 24 hours of each regime
the last 24 hours of each regime
Total duration of hypoglycaemia (glucose ≤ 3.9 mmol/L)
大体时间:during a whole activity regime
during a whole activity regime
Fasting total cholesterol
大体时间:one day after each activity regime
one day after each activity regime
Non-HDL cholesterol
大体时间:one day after each activity regime
one day after each activity regime
HDL cholesterol
大体时间:one day after each activity regime
one day after each activity regime
LDL cholesterol
大体时间:one day after each activity regime
one day after each activity regime
Triglycerides
大体时间:one day after each activity regime
one day after each activity regime
Apolipoprotein B
大体时间:one day after each activity regime
one day after each activity regime
Apolipoprotein A
大体时间:one day after each activity regime
one day after each activity regime
Free fatty acids
大体时间:one day after each activity regime
one day after each activity regime
Fasting glucose
大体时间:one day after each activity regime
one day after each activity regime
Fasting insulin
大体时间:one day after each activity regime
one day after each activity regime
Fasting C-peptide
大体时间:one day after each activity regime
one day after each activity regime
Fasting CRP
大体时间:one day after each activity regime
one day after each activity regime
Fasting IL-6
大体时间:one day after each activity regime
one day after each activity regime
Fasting IL-1
大体时间:one day after each activity regime
one day after each activity regime
Homeostatic model assessment 2 (HOMA2)
大体时间:one day after each activity regime
to assess insulin sensitivity
one day after each activity regime

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。

合作者

调查人员

  • 首席研究员:Nicolaas C Schaper, MD PhD、Maastricht University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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2月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2015年5月1日

研究注册日期

首次提交

2015年1月22日

首先提交符合 QC 标准的

2015年2月19日

首次发布 (估计)

2015年2月25日

研究记录更新

最后更新发布 (估计)

2016年3月16日

上次提交的符合 QC 标准的更新

2016年3月15日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 13-2-050
  • NL45498.068.13 (注册表标识符:Medical Ethical Committee Maastricht University Hospital / University of Maastricht)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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