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Effects of 3 Months of Supervised Exercise Training

2011年5月5日 更新者:University Hospital, Clermont-Ferrand

Effects of 3 Months of Supervised Exercise Training on Cardiometabolic and Inflammatory Biomarkers According to Glucose Tolerance (Normal, Intolerance and Type 2 Diabetes): Measures in Unstimulated and Stimulated Conditions

The incidence of type 2 diabetes is increasing worldwide. Because of cardiovascular morbidity and mortality associated with type 2 diabetes, it is imperative to propose methods of prevention and this in early stage of abnormal glucose metabolism.

This study will assess the beneficial effects of physical activity (acute and chronic effects) (the subjects being their own controls) on cardiometabolic and inflammatory biomarkers in 3 conditions : unstimulated (fasting and resting conditions) and stimulated conditions: postprandial response to a standardized meal preceded or not by an exercise bout.

The investigators hypothesized that an acute bout of exercise will decrease the postprandial inflammatory response to a standardized meal and that this effect of exercise will be increased after 3 months of exercise training.

研究概览

详细说明

This is a prospective study over 4 months, open, nonrandomized. 45 overweight or obese male subjects will complete 3 experimental sessions (0700-1400h) before and after 3 months of supervised physical training. During a first session, subjects will remain inactive and fasted (basal conditions). During the second session a standardized meal will be offered (postprandial response to a standardized meal). The third session will consist in the realization of an exercise bout (60min at 60%VO2 max) followed by a standardized meal (same meal that the previous day).

Several blood (catheter), salivary and urinary samples will be collected during the 3 sessions, throughout the experimental day.

研究类型

介入性

注册 (预期的)

45

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

30年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Male Caucasian Adults between 30 and 65 years old Sedentary criteria based on the determination of fasting glucose (WHO 1999):
  • normal if fasting plasma glucose (FPG) <1.10 g / l
  • diabetes if fasting glucose> 1.26 g / l (7 mmol / l) twice
  • nondiabetic fasting hyperglycemia: 1.10 g / l ≤ FPG ≤ 1.26 g / l
  • glucose intolerance : if plasma glucose at 120 minutes during the OGTT (75g) is between 1.40 g / l and 2 g/ l.

Body mass index 25 BMI 35kg/m2 Affiliated to National Health Insurance Subject giving his written informed consent Subject considered as normal after clinical examination and medical questionnaire

Exclusion Criteria:

  • - drugs that interfere with the parameters determined
  • diabetic treated with insulin, glitazones or glinides
  • eating disorders like bulimia and vomiting
  • special diet, vegan or vegetarian
  • autoimmune disease or inflammatory progressive desease requiring prolonged treatment
  • regular physical activity (> 1 hour of physical activity per week for at least 6 months)
  • smoking (> 5 cigarettes / day)
  • weight change greater than 5% of the total weight in the 3 months preceding the study
  • contra-indication to physical activity
  • chronic pathologies: cancer, inflammatory, cardiac, pulmonary, renal, gastrointestinal or liver diseases
  • Being in exclusion on the National Volunteers Data file
  • No one under guardianship or not subject to social security.
  • Being under someone's supervision
  • Subjects deprived of their liberty by judicial or administrative.
  • Refusal to sign the information sheet and written consent for particip

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:基础科学
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
大体时间
supervised physical training on cardiometabolic and inflammatory biomarkers
大体时间:after 3 months
after 3 months

次要结果测量

结果测量
大体时间
relationships between cortisol secretion and the postprandial inflammatory responses depending on the level of glucose tolerance
大体时间:after 3 months
after 3 months

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

2008年2月1日

初级完成 (预期的)

2011年8月1日

研究完成 (预期的)

2012年2月1日

研究注册日期

首次提交

2011年2月3日

首先提交符合 QC 标准的

2011年5月5日

首次发布 (估计)

2011年5月6日

研究记录更新

最后更新发布 (估计)

2011年5月6日

上次提交的符合 QC 标准的更新

2011年5月5日

最后验证

2011年5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.

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