NCT02157480

Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 2 Diabetes
• Physical Activity

Interventions

Type	Name	Description
DEVICE	electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .	outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2\* (DJO, Vista, CA, USA)
DEVICE	electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week	outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2\* (DJO, Vista, CA, USA)

Timeline

• Start date: 2014-09-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2014-06-06
• Last updated: 2022-08-24

Locations

5 sites across 1 country: France