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临床试验/NCT04142346
NCT04142346已完成不适用

Postprandial Glucose Responses in Trained Older Adults: Effects of Breaking-up Sedentary Time and 2 Weeks Detraining

University of Lisbon1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Continuous glucose monitoring before and after 2-Weeks of detraining for each intervention protocol (prolonged sitting vs. breaking-up sitting)

研究概览

简要总结

Regularly interrupting sedentary behavior (SB) with activity breaks may attenuate postprandial glucose (PPG) excursions and improve glycemic control. The investigators aimed to determine the effect of interrupting 7 hours of prolonged sitting with brief bouts of moderate physical activity (PA) (alternating between up/down stairs and sit/stand up from the chair) on postprandial glucose (PPG) responses in comparison with uninterrupted sitting. In addition, the investigators aimed to examine the effects of 2 weeks of detraining (DT) on PPG on both protocols. Non-diabetic, trained older adults (n = 15) will be recruited for a randomized crossover trial with two treatments performed in two different training conditions: 1) uninterrupted sitting protocol (CON); 2) seated with 2-minutes bouts of moderate PA every 30 minutes (INT). Both protocols will be performed in a trained condition and after 2 weeks of DT. In the early morning of each trial, participants will do an oral glucose tolerance test (OGTT) and 2 blood samples will be collected (fasting and after 2 hours); 2.5 hours after, participants will begin the protocol and two standardized meals will be provided (0 hours and at 3 hours). An iPro2 continuous glucose monitoring (CGM) system will record the average interstitial glucose concentration every 5 minutes. Positive incremental area under the curve (iAUC) and total area under the curve (pAUC) for glucose as well as mean glucose (MG) will be calculated using Matlab. Differences between both protocols and between the two different moments will be examined using generalized estimation equation (GEE), adjusting for sex and age (CI 95%).

详细描述

Participants will be recruited to take part in a randomized crossover trial using media advertisements and group events within the Lisbon Metropolitan Area. In order to be part of this intervention, the participants will have to be men or women aged between 65 and 90 years-old, physically active, and engaged in structured exercise at least twice a week for the past 6 months. People who have diabetes or any type of physical limitation that would prevent them from performing exercise will be excluded. Power and sample size calculations (G-Power 3.1.9.2) were based on an effect size of 0.78 for the glucose iAUC, a power of 0.80, and a significance of 0.05. The calculation yielded a sample size of 15 participants. This study was approved by the Ethics Committee of the Faculty of Human Kinetics (approval number: 06/2019) and conducted in accordance with the Declaration of Helsinki and with the Convention on Human Rights and Biomedicine. Written informed consents were obtained from all participants.

Participants will be followed in a randomized crossover trial undertaken at Faculty of Human Kinetics between April and August 2019. Participants will attend the laboratory on twelve separate occasions: visit 1 (day 1), baseline assessments for body composition; visit 2 (day 2), cardiorespiratory fitness assessment; visit 3 (day 3), OGTT and the first randomized experimental protocol; visit 4 (day 4), follow-up OGTT; visit 5 (4-6 days after the first experimental protocol), OGTT and the remaining experimental protocol; visit 6 (day following the previous experimental protocol), follow-up OGTT. An additional 6 visits will be performed following the same rational, after a 2-week period of detraining, where participants will be instructed to refrain from structured exercise and reduce their physical activity. The follow-up assessments for body composition and cardiorespiratory fitness will be accomplished after the protocols. Experimental protocol order will be randomized at baseline and on the follow-up period after the detraining process by a third party using a computer-generated list of random numbers (block randomization with balanced block sizes).

On the morning of each intervention day, participants will arrive at the laboratory at 8:00 a.m., after a 10h fast. For 48h prior to intervention day, participants will be asked to refrain from structured moderate-to-vigorous physical activity (MVPA), caffeine and alcohol consumption. Each intervention day will have a total duration of 9.5h and will start with an oral glucose tolerance test. After a baseline blood collection, participants will be instructed to drink an oral glucose drink of 75g dissolved in water (200 ml). Two hours after, another blood sample will be drawn.

At 10:30 a.m., a mixed standard meal (breakfast) will be given to the participants, marking the begging of the 7 hour protocol. The same standard meal will be provided at 1:30 p.m. (lunch). The 200-ml meal will consist of 303 kcal, 42g carbohydrate, 10g fat and 11.2g protein, vitamins and minerals (Nestle Health Science - Resource Energy). The participants will be encouraged to consume the entire meal within 5 minutes. The protocols performed will be: 1) uninterrupted sitting: participants will remain seated throughout 7 hours (SIT); 2) Sitting + moderate intensity breaks: participants will be instructed to sit throughout 7 hours, while interrupting the sitting position every 30 minutes to perform 2 minutes of moderate-intensity physical activity. The breaks will consist of walk up and down the stairs and squats. Each person will perform these exercises alternately. During the protocol, participants will be allowed to go to the bathroom in a wheelchair and al-libitum water will be granted. The following morning after the protocol, the OGTT will be repeated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men or women
  • 65 and 90 years-old
  • Physically active
  • Engaged in structured exercise at least twice a week for the past 6 months.

排除标准

  • Diagnosed with diabetes
  • Any type of physical limitation that would prevent them from practicing exercise

结局指标

主要结局

Continuous glucose monitoring before and after 2-Weeks of detraining for each intervention protocol (prolonged sitting vs. breaking-up sitting)

时间窗: 1-month (2 measurement times, one for each protocol, including baseline and after detraining)

Immediately upon arrival at the laboratory and throughout 24h, a blood glucose monitor (iPro2 CGM with Enlite Sensors MiniMed; Medtronic, Northridge, California, USA) will be placed on the right side of the abdomen. Once inserted, CGM provides interstitial glucose values every 5 minutes. To calibrate the CGM, four capillary blood glucose samples (three in the laboratory and one at home) will be collected and measured using a glucometer (Contour Next One, Ascensia Diabetes Care, Basel, Switzerland).

次要结局

  • Body Composition(1-month (2 measurement times (one at baseline and after two weeks of detraining)))
  • Objective Measures of Physical Activity(1-month (2 measurement times (one week at baseline and during the two weeks of detraining)))
  • Objective Measures of Sedentary Time(1-month (2 measurement times (one week at baseline and during the two weeks of detraining)))
  • Lower limb muscle strength(1-month (2 measurement times (one at baseline and after two weeks of detraining)))
  • Weight(1-month (2 measurement times (one at baseline and after two weeks of detraining)))
  • Upper limb muscle strength(1-month (2 measurement times (one at baseline and after two weeks of detraining)))
  • Cardiorespiratory fitness (CRF)(1-month (2 measurement times (one at baseline and after two weeks of detraining)))
  • Postural allocation(1-month (2 measurement times, one for each protocol, including baseline and after detraining))
  • Oral Glucose Tolerance Test(1-month (4 measurement times, two for each protocol (in the morning of each protocol day and the day after), including baseline and after detraining))
  • Height(1-month (2 measurement times (one at baseline and after two weeks of detraining)))
  • Phase angle (PhA)(1-month (2 measurement times (one at baseline and after two weeks of detraining)))
  • Body Water(1-month (2 measurement times (one at baseline and after two weeks of detraining)))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luís Bettencourt Sardinha

Professor

University of Lisbon

研究点 (1)

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