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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|