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临床试验/NCT02157480
NCT02157480已完成不适用

ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.

University Hospital, Caen7 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
7
主要终点
Mean CGM glucose from a 6-day CGM recording

研究概览

简要总结

Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the cornerstone treatment for patients with T2D who are often overweight and sedentary.

Physical activity improves glucose metabolism of patients with T2D : increased glucose utilization during acute muscle activity and improved insulin sensitivity after regular training. The molecular mechanism underlying the effects of exercise on glucose metabolism involves the glucose transporter GLUT-4 which is regulated by physical activity.

Several studies and meta-analysis have showed that physical activity reduces HbA1c by 0.6% on average. In addition, other data suggest a decrease in cardiovascular morbidity and mortality through physical activity.

Recent recommendations for T2D management call for the practice of a structured type of endurance 150 minutes per week and muscle building 2 times per week. However, implementation of these recommendations is low, even when integrated into a therapeutic education program. Adherence is often transient and / or partial. In addition, many T2D subjects are unable to initiate a physical activity because of disabling complications or comorbidities or because of a major cardiorespiratory deconditioning.

Neuro-myo electrical stimulation (NMES) is a physical treatment routinely used in functional rehabilitation to improve muscle strength and volume. The metabolic effect of NMES has been little studied. A pilot study conducted by our team on a population of 18 subjects with T2D showed that a week of daily NMES sessions significantly improved insulin sensitivity of about 25% and up to 50 % for good responders. This result contrasted with the low induced energy expenditure by each 20-minute session of bi-quadricipital NMES, suggesting the possibility of a humoral or neural mechanism associated with NMES.

To complete this work, we plan a randomized cross-over trial with 3 periods (6 weeks without NMES (control), 6 weeks with 3 sessions of NMES per week and 6 weeks with 5 sessions of NMES per week) to assess the glucose profile of sedentary T2D subjects during these different periods. We hypothesize that the bi-quadricipital NMES could improve glycemic control in T2D subjects and thus represent an alternative to traditional physical activity.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes treated with lifestyle, oral hypoglycemic agents and/or GLP-1 agonists.
  • HbA1c : 7 to 10%
  • low physical activity (Ricci and Gagnon score below 27)
  • Insulin-resistance (at least one criteria out three):
  • Waist circumference > 80cm in women and > 94cm in men
  • Triglycerides > 150 mg/dl
  • HDL-c < 50 mg/dl for women, < 40 mg/dl for men

排除标准

  • type 1 diabetes
  • pregnancy
  • intense usual physical activity
  • pace maker
  • knee or neuromuscular pathology

结局指标

主要结局

Mean CGM glucose from a 6-day CGM recording

时间窗: week 0, 6, 13, 20

次要结局

  • HbA1c(week 0, 6, 13, 20)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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