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临床试验/NCT02292810
NCT02292810Unknown不适用

Acute Effects of Inspiratory Muscle Exercise on Glucose Level and Glucose Variability in Patients With Type 2 Diabetes.

Hospital de Clinicas de Porto Alegre0 个研究点目标入组 14 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
14
主要终点
Glucose level

研究概览

简要总结

Type 2 diabetes is associated with respiratory muscle weakness and autonomic neuropathy. The exercise of inspiratory muscles has been investigating in various clinical situations and may cause similar benefits as the conventional exercises. The assessment of glucose variability has been used as an alternative tool to evaluate the others mechanisms than the absolute values of glucose levels, special during the exercise. However, the effect of inspiratory muscle exercise on glucose levels and glucose variability is not clear yet. The aim of the proposed research is to evaluate the acute effects of inspiratory muscle exercise using a high load of 60% of MIP on glucose levels and glucose variability in patients with type 2 diabetes.

详细描述

High-intensity exercise of inspiratory muscle was able to reduce glucose levels in previous studies, but the mechanisms underlying this reduction remain largely unknown. The present study will investigate this phenomenon, and whether confirmed, the inspiratory muscle loading would be a new approach for lowering glucose levels and glucose variability in type 2 diabetes.

The subjects with type 2 diabetes will be recruited from the ambulatory of the Hospital de Clinicas de Porto Alegre. The patients will be randomized to inspiratory muscle exercise with a high intensity load (MIP 60%) or to exercise with a load placebo (MIP 2%), on two different days. The subjects will come in the laboratory for three days consecutively during 2 weeks. On the first day will be placed the CGMS device. On the second day will be the controlled ventilation protocol with subsequently inspiratory muscle exercise, using 2% or 60% of MIP as randomized a priori. On the third day the CGMS will be removed. Individuals who are using beta-blockers will be advised to withdraw the medication 24 hours before the protocols. During all protocols will be recorded the continuous blood pressure to assess heart rate and blood pressure variabilities, both time and frequency domains will be analyzed. Also, the calf blood flow, inspiratory pressure, end-tidal carbon dioxide and oxygen saturation will be taking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Type 2 diabetes;
  • HbA1c from 7,5 to 10%;

排除标准

  • Subjects taking insulin;
  • Pregnant women;
  • Subjects taking betablocker only
  • Documented arrythmia
  • Documented fibrillation
  • Documented pulmonary disease or asthma,
  • Current smoking;
  • Varicose vein problems;
  • Musculoskeletal disease.

结局指标

主要结局

Glucose level

时间窗: 1 day (A session of inspiratory muscle exercise)

The glucose level will be assessed by continuous glucose monitoring (CGMS) before and after exercise.

次要结局

  • Glucose variability(3 days)
  • Autonomic control(1 day (A session of inspiratory muscle exercise))

研究者

申办方类型
Other
责任方
Sponsor

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