Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes (ELECTRODIAB2)
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|ClinicalTrials.gov Identifier: NCT02157480|
Recruitment Status : Unknown
Verified January 2016 by University Hospital, Caen.
Recruitment status was: Recruiting
First Posted : June 6, 2014
Last Update Posted : February 10, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Physical Activity||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||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
No Intervention: control
usual follow-up for 6 weeks
Experimental: electrostimulation 3 days per week
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 .
outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)
Experimental: electrostimulation 5 days per week
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
outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)
- Mean CGM glucose from a 6-day CGM recording [ Time Frame: week 0, 6, 13, 20 ]
- HbA1c [ Time Frame: week 0, 6, 13, 20 ]
- fasting plasma glucose [ Time Frame: Week 0, 6, 13, 20 ]
- fasting plasma insulin [ Time Frame: Week 0, 6, 13, 20 ]
- FFA (free fatty acid) [ Time Frame: Week 0, 6, 13, 20 ]
- IL6 (interleukin 6) [ Time Frame: Week 0, 6, 13, 20 ]
- TNFalpha [ Time Frame: Week 0, 6, 13, 20 ]
- adiponectin [ Time Frame: Week 0, 6, 13, 20 ]
- CRPus (C Reactive Protein ultra sensitive) [ Time Frame: Week 0, 6, 13, 20 ]
- irisin [ Time Frame: Week 0, 6, 13, 20 ]
- satisfaction questionnaire [ Time Frame: Week 0, 6, 13, 20 ]
- motivation questionnaire for physical activity [ Time Frame: Week 0, 6, 13, 20 ]
- cardiometabolic stress test [ Time Frame: Week 6, 20 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157480
|Contact: Michael JOUBERT, MDfirstname.lastname@example.org|
|University Hospital Amiens||Recruiting|
|Contact: Rachel DESAILLOUD|
|Clinical Research Center University Hospital Caen||Recruiting|
|Caen, France, 14033|
|Contact: Sylvie BRUCATO, PhD +33231065227 email@example.com|
|University Hospital Lille||Recruiting|
|Contact: Pierre FONTAINE, MD|
|General Hospital Roubaix||Recruiting|
|Contact: Catherine FERMON|
|Rouen, France, 76000|
|Contact: Gaetan prevost, MD|
|Principal Investigator:||Corinne FOURMY, MD||University Hospital, Caen|