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

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Physical Activity
• Interventions: Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week; Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .

• Registration Number: NCT02157480
• Lead Sponsor: University Hospital, Caen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-06
• Study Start: 2014-09
• Status Verified: 2022-07
• Primary Completion: 2022-07
• Study Completion: 2022-07
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
electrostimulation 5 days per week	electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week	20 minutes ambulatory bi-quadricipital electrostimulation sessions five times per week for 6 weeks
electrostimulation 3 days per week	electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .	20 minutes ambulatory bi-quadricipital electrostimulation sessions three times per week for 6 weeks

Primary Outcome Measures

Name	Time	Method
Mean CGM glucose from a 6-day CGM recording	week 0, 6, 13, 20

Secondary Outcome Measures

Name	Time	Method
HbA1c	week 0, 6, 13, 20

Trial Locations

Locations (5)

University Hospital Amiens; 🇫🇷 Amiens, France

Clinical Research Center University Hospital Caen; 🇫🇷 Caen, France

General Hospital Roubaix; 🇫🇷 Roubaix, France

University Hospital Lille; 🇫🇷 Lille, France

CHU Rouen; 🇫🇷 Rouen, France