跳至主要内容
临床试验/NCT02171351
NCT02171351撤回不适用

Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)

University Hospital, Caen1 个研究点 分布在 1 个国家开始时间: 2020年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Sympathetic nerve reactivity in response to a single session of neuromuscular electrostimulation

研究概览

简要总结

Physical activity (PA) is recommended for the treatment of subjects with type 2 diabetes to increase insulin sensitivity and improve metabolic control. However, adherence to PA is often poor, due to a lack of motivation or due to disabling complications or comorbidities. Neuromuscular electrostimulation (NMES) is a physical treatment commonly used to improve muscle strength and volume in several situations: after stroke, after limb trauma or during chest rehabilitation in deconditioned patients. The investigators have already shown in a first pilot study (manuscript in preparation) that NMES improves insulin sensitivity : in the study ELECTRODIAB (No. ID-RCB: 2011-A00930-41), the investigators showed a 25% insulin sensitivity improvement after a week of daily 25-min bi-quadricipital NMES session, in a population of patients with orally-treated type 2 diabetes. Insulin sensitivity increased up to 50% in the most deconditioned subjects. Discrepancy between this result and the very low energy expenditure measured during sessions suggests that the metabolic effect was not solely mediated by muscle contractions. The investigators hypothesize the involvement of neurological pathways. Indeed, it is demonstrated that the autonomic nervous system is an important regulator of glucose metabolism with pancreatic action, a key role in energy metabolism and a complex relationship with insulin resistance. Muscle activity, whether static (isometric) or dynamic causes changes in sympathetic nerve activity in healthy subjects but its effect in type 2 diabetic subjects is not known. The investigators hypothesize that, in type 2 diabetic subjects, the modulation of sympathetic nerve activity by NMES could be involved in the improvement of insulin sensitivity. To address this question, the investigators propose to assess sympathetic nerve activity with the gold standard method of microneurography before and after a single bi-quadricipital NMES session. The impact of neuro-electro-stimulation (NES) (a sensitive stimulation under muscular threshold) and the impact of voluntary isometric muscle contractions (VC) will also be evaluated. These procedures will also be applied in healthy control subjects.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •type 2 diabetes for at least 12 month
  • •treatment by oral hypoglycemic agents and/or GLP1 agonists
  • •HbA1c : 6-10%
  • •suspected insulin-resistance (at least one criteria below) :
  • •waist circumference > 80cm (female); > 94cm (male)
  • •triglycerides > 150 mg/dl
  • •HDL-cholesterol < 50 mg/dl (female); < 40 mg/dl (male)
  • •low background physical activity (Ricci-Gagnon score < 27)

排除标准

  • •type 1 diabetes
  • •treatment with insulin
  • •pace maker

研究组 & 干预措施

effect of neuromuscular electrostimulation (NMES)

Experimental

干预措施: effect of neuromuscular electrostimulation (NMES) (Device)

effect of neuro electrostimulation (NES)

Experimental

干预措施: effect of neuro electrostimulation (NES) (Device)

effect of voluntary contractions (VC)

Experimental

干预措施: effect of voluntary contractions (VC) (Other)

结局指标

主要结局

Sympathetic nerve reactivity in response to a single session of neuromuscular electrostimulation

时间窗: at 0, 5, 10, 15, 20 min of the NMES session

Sympathetic nerve reactivity will be assessed by plethysmography, with a Valsalva procedure, at baseline and every 5 minutes during a 20-min session of biquadricipital neuromuscular electrostimulation

次要结局

  • sympathetic nerve reactivity in response to a single session of voluntary muscular contractions(at 0, 5, 10, 15, 20 min of the VC session)
  • sympathetic nerve reactivity in response to a single session of neuro electrostimulation(at 0, 5, 10, 15, 20 min of the NES session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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