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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes, Physical Activity

Intervention / Treatment
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* Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .
* Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: type 1 diabetes pregnancy intense usual physical activity pace maker seizure knee or neuromuscular pathology

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>usual follow-up for 6 weeks | |
| Experimental: electrostimulation 3 days per week<br>20 minutes ambulatory bi-quadricipital electrostimulation sessions three times per week for 6 weeks | Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .<br>* outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)<br>|
| Experimental: electrostimulation 5 days per week<br>20 minutes ambulatory bi-quadricipital electrostimulation sessions five times per week for 6 weeks | Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week<br>* outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean CGM glucose from a 6-day CGM recording |  | week 0, 6, 13, 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | week 0, 6, 13, 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose profile, continuous glucose monitoring, electrostimulation