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临床试验/NCT03847779
NCT03847779已完成不适用

Microcirculatory Vasomotor Function in Response to Acute Exercise in Type 2 Diabetes With Peripheral Neuropathy

University of Avignon2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2019年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
2
主要终点
Changes in average spectral amplitude of the entire frequency range between baseline and after stimulus

研究概览

简要总结

Microcirculatory flow is subject to cyclic changes under the influence of heart rate, respiration, myogenic activity, neurogenic factors and endothelial factors. Microcirculatory oscillations (vasomotion) contribute significantly to tissue perfusion. Vasomotion analysis allowed to discriminate normoglycemic subjects, prediabetic subjects and diabetic subjects. Furthermore, changes in vasomotion can precede the emergence of global signs of microangiopathy complications in type 2 diabetes. In fact, few studies reported impaired vasomotion in type 2 diabetes with peripheral neuropathy. Vasomotion analysis after vasodilator (6-min walking test and hyperthermia) and after vasoconstrictor (foot lowering) stimulus could be an effective diagnostic tool to sharpen the diagnostic.

Objectives and Methodology: to study vasomotion at baseline and after exercise, hyperthermia and foot lowering within 3 groups of patients: diabetic without peripheral neuropathy, diabetic with subclinical peripheral neuropathy and diabetic with peripheral neuropathy and one group of sex- age- and body mass index-matched healthy control subjects.

All the subjects will benefit from a clinical, anthropometric, level of physical activity and biological evaluations. Type 2 diabetes participants will benefit from neuropathy evaluation. In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).

详细描述

All the subjects will benefit from a:

  • clinical: diabetes duration, treatments
  • anthropometric: weight, height, BMI
  • level of physical activity by means of the International Physical Activity Questionary, pedometers and the 6 minutes walking test
  • biological evaluations: glycemia, HbA1C, lipids, high sensitive C-reactive protein, fibrinogen, 25(OH)D, creatinine, albumine Type 2 diabetes participants will benefit from neuropathy evaluation: sensory tests by means of Semmes-Weinstein monofilament and of Nerve Check, amplitude and velocity sural nerve and neuropathic symptom score (NSS) In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).

研究设计

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

入排标准

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

入选标准

  • For diabetic patients, HbA1C >6.5 and diabetes duration >5years
  • For healthy control no diabetes mellitus, no cardiovascular or renal pathology

排除标准

  • nondiabetic neuropathy
  • on medication known to affect microcirculation
  • presence of active foot ulcer or wound healing history <3months
  • inability to walk 6 minutes
  • alcohol consumption of more than 3 units per day

结局指标

主要结局

Changes in average spectral amplitude of the entire frequency range between baseline and after stimulus

时间窗: Cutaneous blood flow will be recorded during 20 minutes at rest, 10 minutes after foot lowering, 15 minutes after exercise and 20 minutes during hyperthermia

Spectral analysis by wavelet analysis

次要结局

未报告次要终点

研究者

发起方
University of Avignon
申办方类型
Other
责任方
Sponsor

研究点 (2)

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