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临床试验/NCT01349166
NCT01349166Unknown不适用

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

University Hospital, Clermont-Ferrand0 个研究点目标入组 45 人开始时间: 2008年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
主要终点
supervised physical training on cardiometabolic and inflammatory biomarkers

研究概览

简要总结

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.

详细描述

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.

研究设计

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

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • - 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

结局指标

主要结局

supervised physical training on cardiometabolic and inflammatory biomarkers

时间窗: after 3 months

次要结局

  • relationships between cortisol secretion and the postprandial inflammatory responses depending on the level of glucose tolerance(after 3 months)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other

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