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临床试验/NCT03869411
NCT03869411已完成不适用

Effects of Exercise Intervention and Confounding Factors on Type II Diabetic Muscles

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月15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
60
试验地点
2
主要终点
muscle microcirculation

研究概览

简要总结

The aim of the first year of this three-year plan is to analyze and compare the muscle quality of lower limb muscle (microcirculation, muscle performance and mechanical characteristics) and maximal aerobic exercise capacity in treadmill exercise tests for diabetic and non-diabetic cases. The hypotheses are:1) the muscle quality of lower limb muscle and maximal aerobic exercise capacity are different between participate with diabetic and non-diabetic, 2) the effect of the three-month aerobic exercise intervention or home exercise on the characteristics of the muscle quality are different , and 3) intrinsic factors (such as age, BMI, and HDL) and characteristics of specific FTO genes are influenced the training outcomes.

详细描述

Participants with diabetes will attend an 12-week aerobic exercise intervention or home exercise if the exercise test result of the maximum rate of oxygen consumption is fair or poor. Assessments will be taken before and after the training program, which including muscle strength, stiffness, quality, microcirculation and exercise capacity. Comparisons between the pre-training and post-training condition will be made for each groups. And the assessments also compare with the healthy control group.

研究设计

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

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetes group: 1) Age between 30-70 years of old, 2) type 2 diabetes.
  • Healthy control group: 1) Age between 30-70 years of old, 2) without diabetes

排除标准

  • history of moderate-severe somatic or autonomic neuropathy, cardiovascular disease, preproliferative or proliferative retinopathy, and chronic renal failure
  • unable to perform the programs or assessments
  • other systematic diseases

结局指标

主要结局

muscle microcirculation

时间窗: Change from Baseline muscle quality at 3 months

Near-infrared spectroscopy was used to measure oxygen saturation on muscle, units on percentage

muscle strength of knee extensor and plantarflexor

时间窗: Change from Baseline functional performance at 3 months

Dynamometer was used to measure muscle strength, units on kilograms

maximum rate of oxygen consumption

时间窗: Baseline

Bruce treadmill protocol was used in the maximal exercise testing, maximum rate of oxygen consumption record as ml/kg/min

index of muscle stiffness

时间窗: Change from Baseline muscle quality at 3 months

elastography was used, units on kPa

Relative sliding of muscles

时间窗: Change from Baseline muscle quality at 3 months

B mode sonography was used, units on mm/s

次要结局

  • characteristics of specific FTO genes(Baseline)
  • physical activity level(Change from Baseline functional performance at 3 months)
  • blood cholesterol(Change from Baseline functional performance at 3 months)
  • blood glucose level(Change from Baseline functional performance at 3 months)
  • BMI(Change from Baseline functional performance at 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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