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临床试验/NCT02872922
NCT02872922已完成不适用

Effects of Therapeutic Ultrasound on Endothelial Function of Patients With Type 2 Diabetes Mellitus: Randomized Clinical Trial

Universidade Federal de Santa Maria2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年12月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Percentage of the endothelium-dependent vasodilation (%FMD)

研究概览

简要总结

Endothelium is a cell layer that interposes blood and smooth muscle of vessels. This biological sensor reacts to physical and chemical stimuli by synthesis and/or liberation of regulatory substances like nitric oxide (NO), which acts on vascular tone, growth of muscle cells and platelet aggregation and leukocyte. Clinically, endothelial function measured by technique flow-mediated dilation (FMD) is a strong predictor of cardiovascular events and all-cause mortality. Previo study demonstrated that continuous and pulsed therapeutic 1-MHz ultrasound waveforms improved endothelial function in health volunteers and this vasodilation persisted for 20 min, which provided them with anti-inflammatory vascular effects. In subjects with type 2 diabetes (DM2) the chronical hyperglycemia and dyslipidemia reduce NO bioavailability causing endothelial dysfunction. Low intensity therapeutic ultrasound is an electrotherapeutic instrument employed in musculoskeletal injuries that promotes endothelium-dependent vasodilation, and its mechanism of action has not been studied on DM2. The aim of our study is evaluate endothelial function of patients with DM2 after different waveforms (placebo, continuous and pulsed) of therapeutic ultrasound. Therapeutic ultrasound is a electrotherapeutic instrument that can changes arterial endothelial function of subjects with DM2 because of NO bioavailability increasing, which implies anti-inflammatory and vasodilatory beneficial alterations for diabetic patients.

详细描述

Evaluation of endothelial function will be made by flow-mediated dilation (FMD). The therapeutic ultrasound will applied over brachial artery using continuous (CUT: 0,4W/cm2), pulsed (PUT: 20% duty cycle, 0,08W/cm2SATA) and Placebo (equipment off) waveforms during 5min in 3 intercalated days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • The subjects that joined the study will be alphabetized volunteers
  • Age between 25 and 65 years old,
  • Absence of morbid obesity,
  • Non-smokers,
  • With no symptoms of skeletal muscle disorders,
  • No previous performing cardiovascular surgery,
  • No previous diagnose of rheumatic, neurological, oncological, immune or hematologic diseases,
  • Without evidence of psychiatric diseases and/or cognitive deficit.

排除标准

  • Insulin dependent diabetes
  • Leukocytosis, impaired fasting glycemia (<70 and >300 mg/dL) and
  • Brachial artery diameter less than 2.5mm and larger than 5.0mm.
  • On the day of the assessments have consumed of the alcoholic drink, caffeine and citrus juice

研究组 & 干预措施

Endothelial function after CWUT

Active Comparator

Endothelial function of the all patients before and after application continuous waveform of ultrasound therapy (CWUT) measured by technique flow-mediated dilation (FMD).

干预措施: Low intensity therapeutic ultrasound (Other)

Endothelial function after PWUT

Active Comparator

Endothelial function of the all patients before and after application pulsed waveform of ultrasound therapy (PWUT) measured by technique flow-mediated dilation (FMD).

干预措施: Low intensity therapeutic ultrasound (Other)

Endothelial function after PLACEBO

Active Comparator

In the placebo intervention, all of the procedures above are repeated, but with the ultrasound equipment powered off. Endothelial function of the all patients before and after application placebo waveform of ultrasound therapy measured by technique flow-mediated dilation (FMD)

干预措施: Low intensity therapeutic ultrasound (Other)

结局指标

主要结局

Percentage of the endothelium-dependent vasodilation (%FMD)

时间窗: Five minutes after application of therapeutic ultrasound

Vessel diameter responses to reactive hyperemia are expressed as percentage change in relation to diameter before cuff inflation (%FMD = \[(hyperemia maximum diameter - baseline precuff diameter)/(baseline precuff diameter)\] / 100) (Corretti et al. 2002; Thijssen et al. 2011). Baseline precuff diameter is expressed in millimeter (mm). Hyperemia maximum diameter is expressed in millimeter (mm). Arterial endothelium-dependent vasodilation are evaluated by technique flow-mediated dilation (FMD) with high-resolution vascular ultrasound and a 5- to 12-MHz linear transducer (Logiq P6, GE Healthcare, GE Ultrasound Korea), according to the American Heart Association Guidelines (Corretti et al. 2002), with adjustments (Thijssen et al. 2011).

次要结局

  • Percentage of the endothelium-independent vasodilation (%NMD)(Five minutes after application of therapeutic ultrasound)

研究者

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

Luis Ulisses Signori

PhD

Universidade Federal de Santa Maria

研究点 (2)

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