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临床试验/NCT03773731
NCT03773731Unknown不适用

Impact of High Intensity Interval Training vs. Continuous Aerobic Training on Platelet Insulin Resistance, Platelet Function and Hepatic Steatosis in Patients With Prediabetes

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
44
试验地点
2
主要终点
EC50 (half-maximal effective concentration) of TRAP-6 (thrombin-receptor activating peptide) in terms of surface CD62P (=platelet selectin, P-selectin) expression: group differences after 12 weeks of training

研究概览

简要总结

This trial investigates if high intensity interval training is more effective than moderate intensity continuous training in suppressing platelet reactivity and hepatic fat content in prediabetic individuals.

详细描述

Background:

The prevalence of type 2 diabetes mellitus (T2DM) is rising dramatically. T2DM represents a major cause for cardiovascular disease -related mortality and morbidity and increasingly burdens healthcare systems. While the fundamental pathomechanism of T2DM is insulin resistance of muscle and adipose tissue, recent studies demonstrate that insulin resistance in T2DM also occurs in platelets. As insulin directly inhibits platelet function, this mechanism might contribute to platelet activation and platelet hyperreactivity, which were in fact detected in diabetic patients. Since (inadvertent) platelet activation is causally linked to the development of atherosclerosis and atherothrombosis, regulation of platelet function is of utmost importance. Exercise training, performed on a regular basis has been shown to reduce morbidity and mortality in sedentary and diseased populations. Furthermore, exercise training improves whole body insulin sensitivity - however, it is currently unclear, if exercise training also affects insulin sensitivity of platelets. Recently, a time-saving interval training protocol has been adapted for T2DM-patients. Since this adapted high intensity interval training (HIIT) needs a fractional time commitment of exercise training according to current guidelines, HIIT possibly represents a promising instrument to increase adherence to exercise and thereby reduce T2DM morbidity.

Aims:

The primary aim of this study is to investigate the effect of 12 weeks of HIIT vs. continuous training (CT) on platelet insulin sensitivity and platelet (hyper)reactivity in prediabetic patients.

Secondary aims are to assess the effect of HIIT and CT on whole body insulin sensitivity and fitness in prediabetic patients as well as on various parameters of platelet function and on the hepatic fat content.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • prediabetic (insulin-insensitive) patients
  • either fasting plasma glucose 100- 125 mg/dl or HbA1c 5.7 - 6.4
  • < 3kg bodyweight change within the last 6 months

排除标准

  • Any contraindications for exercise
  • resulting from anamnesis ( e.g. history of angina pectoris, peripheral arterial disease), ECG at rest or during graded exercise test, echocardiogram, echocardiography or lung function test
  • chronical joint pain that makes exercise training on bicycle ergometers impossible
  • any conditions that make the successful participation in the study unlikely
  • islet cell autoantibodies
  • Medication: insulin, thiazolidindiones, statins, antidepressants
  • Secondary diseases: History of end-stage liver or kidney disease; pronounced neuropathy or retinopathy
  • drug or alcohol abuse

研究组 & 干预措施

High intensity interval training

Experimental

3x/week the following 45 min training protocol on bicycle ergometer for 12 weeks:

  • 5 minutes warm-up phase with a power output of 40% of the maximal power output achieved in an incremental exercise test
  • 30 minutes: intensive cycling bouts of 60s interspersed with 60s of recovery intervals. Power output will be 90% (week 1-6) or 95% (week 7-12) of the maximal power output of the exercise test during the intensive cycling bouts. During recovery intervals, subjects will pedal with a power output of 30% (week 1-6) or 35% (week 7-12) of the maximal power output of the exercise test.
  • 10 minutes with 30% of maximal power output.

干预措施: High intensity interval training (HIIT) (Behavioral)

Moderate intensity continuous training

Active Comparator

3x/week the following 45 min training protocol on bicycle ergometer for 12 weeks:

  • 5 minutes warm-up phase with a power output of 40% of the maximal power output achieved in an incremental exercise test
  • 30 minutes: Continuous training with 60% (week 1-6) or 65% (week 7-12) of maximal power output
  • 10 minutes with 30% of maximal power output.

干预措施: Moderate intensity continuous training (MICT) (Behavioral)

结局指标

主要结局

EC50 (half-maximal effective concentration) of TRAP-6 (thrombin-receptor activating peptide) in terms of surface CD62P (=platelet selectin, P-selectin) expression: group differences after 12 weeks of training

时间窗: 12 weeks

EC50 of insulin in terms of intraplatelet VASP (vasodilator-stimulated phosphoprotein)-phosphorylation: group differences after 12 weeks of training

时间窗: 12 weeks

次要结局

  • Maximal oxygen consumption(12 weeks)
  • whole body insulin sensitivity(12 weeks)
  • EC50 of other platelet agonists in terms of various platelet activation markers(12 weeks)
  • EC50 of prostacyclin in terms of intraplatelet VASP-phosphorylation(12 weeks)
  • Transient elastography (FibroScan®) controlled attenuation parameter (CAP)(12 weeks)
  • Fatty Liver Index (FLI)(12 weeks)

研究者

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

Stefan Heber

Dr.med.univ. Dr.rer.nat.

Medical University of Vienna

研究点 (2)

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