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Low Intensity Physical Activity During Sitting on Glycemic Control and Vascular Function in Obese Individuals

2020年3月23日 更新者:Jill Kanaley、University of Missouri-Columbia

The Impact of Low Intensity Physical Activity During Sitting on Glycemic Control and Vascular Function in Obese Individuals

Prolonged sitting is a common behavior in contemporary humans. In epidemiological studies, increased sitting time has been associated with increased risk for cardiovascular disease and all-cause mortality. Recent research has also shown that interrupting sitting time with standing prevents the poorer glycemic control. However, studies are lacking which evaluate the impact of low intensity physical activity during prolonged sitting on vascular function. Whether low intensity physical activity can increase blood flow substantially and prevent impairment in vascular function and glycemic control is unknown.

The purpose of the present study is to evaluate whether increased blood flow during sitting via low intensity physical activity (fidgetting) prevents the impairment in vascular function and poorer glycemic control associated with prolonged sitting.

研究概览

详细说明

Experimental Design: Twenty obese subjects with metabolic syndrome will complete 2 study days with measures vascular function and glycemic control. On one study day, the subjects will sit quietly for 3 hours and on the second study day subjects will sit quietly for 3 hours and simultaneously move their legs using fidgetting.

VISIT 1: All visits will be in Gwynn Hall. On this visit subjects will be consented in the following manner: a review of the inclusion/exclusion criteria and discussion of the informed consent form including an oral explanation of the study purpose, protocol, and potential risks and benefits. Potential subjects will be given time to read the consent form and ask questions of the study personnel. After signing the informed consent, the popliteal artery will be imaged by Doppler ultrasound to ensure that the subject is a candidate for the study. Body composition will be measured and waist measurements will be made. Questionnaires will be filled out. Subjects will be asked to fill out a one day food record on the day prior to each study visit.

VISIT 2 and 3: Upon arrival to the laboratory, subjects will be asked to use the bathroom and height and weight measurements will be taken. An IV will be placed in a forearm vein. Subjects will then be asked to lie down and they will be instrumented for baseline assessment of blood pressure and flow-mediated dilation in the popliteal artery.

Energy expenditure (EE): A ParvoMedics TrueOne2400 metabolic measurement system (Sandy Lake, UT) will be used to measure EE. The EE measurement will occur throughout the sitting period on both study visits. During the measures, a mask will be placed on their face to collect their expired air. The air will be analyzed for O2 and CO2 content. The participants will be able to breathe room air normally during the procedure. This measurement will be made prior to ingesting the glucose and periodically throughout the sitting period.

After baseline assessments, the subject will be asked to drink a 75 g glucose drink. On one occasion, subjects will then sit in a comfortable chair with minimal movement. On the second study day, subjects will sit comfortably in a chair but will continuously move their legs by fidgetting. Subjects will be allowed to move their arms (e.g., use computer or read) although not vigorously. The rationale for maintaining activity in the legs is to increase muscle blood flow and thus increase shear stress. The subject will have access to a bathroom using a wheelchair if needed. Every hour, 3 assessments of blood pressure and leg blood flow will be made while the subject remains in the sitting position. After the 4-hour sitting period, subjects will lie down again for post-sitting assessment blood pressure and flow-mediated dilation.

Following the consumption of the glucose, a small blood sample will be taken every ½ hour for 3 hours. These samples will be used to measure glucose, insulin, glucagon, and c-peptide.

研究类型

介入性

注册 (实际的)

20

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

    • Missouri
      • Columbia、Missouri、美国、65211
        • University of Missouri

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

20年 至 60年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Obese males and females with metabolic syndrome, aged 20-60 years old.

According to the NCEP ATP III definition, metabolic syndrome is present if three or more of the following five criteria are met:

  • waist circumference over 40 inches (men) or 35 inches (women),
  • blood pressure over 130/85 mmHg,
  • fasting triglyceride (TG) level over 150 mg/dl,
  • fasting high-density lipoprotein (HDL) level less than 40 mg/dl (men) or 50 mg/dl (women)
  • fasting blood sugar over 100 mg/dl.

Exclusion Criteria:

  1. they smoke
  2. they have any known cardiovascular, pulmonary or metabolic disease
  3. have type 2 diabetes
  4. if good quality Doppler ultrasound image of their arteries cannot be obtained and/or evidence of plaque.

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:预防
  • 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
实验性的:Glucose and Fidgetting
75 g of glucose will be given at the beginning of the study day (days one with glucose+fidgeting )
Glucose
low intensity physical activity (fidgetting)
其他名称:
  • 低强度体力活动
安慰剂比较:Fidgetting
Subjects will fidget their legs in an up and down motion for 2.5 min on and then 2.5 min off for the duration of the study.
low intensity physical activity (fidgetting)
其他名称:
  • 低强度体力活动

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
glucose tolerance
大体时间:3 hr
glucose area under the curve
3 hr
flow mediated dilation
大体时间:every 30 min over 3 hr
flow
every 30 min over 3 hr

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 (实际的)

2018年3月20日

初级完成 (实际的)

2020年3月1日

研究完成 (实际的)

2020年3月1日

研究注册日期

首次提交

2018年1月20日

首先提交符合 QC 标准的

2018年1月26日

首次发布 (实际的)

2018年2月5日

研究记录更新

最后更新发布 (实际的)

2020年3月24日

上次提交的符合 QC 标准的更新

2020年3月23日

最后验证

2020年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • Fidget

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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

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.

Glucose的临床试验

3
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