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| Name | Class |
|---|---|
| University Hospital, Rouen | OTHER |
| Amiens University Hospital | OTHER |
| University Hospital, Lille | OTHER |
| General Hospital Roubaix |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | usual follow-up for 6 weeks | |
| electrostimulation 3 days per week | Experimental | 20 minutes ambulatory bi-quadricipital electrostimulation sessions three times per week for 6 weeks |
|
| electrostimulation 5 days per week | Experimental | 20 minutes ambulatory bi-quadricipital electrostimulation sessions five times per week for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week . | Device | outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean CGM glucose from a 6-day CGM recording | week 0, 6, 13, 20 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | week 0, 6, 13, 20 |
| Measure | Description | Time Frame |
|---|---|---|
| fasting plasma glucose | Week 0, 6, 13, 20 | |
| fasting plasma insulin | Week 0, 6, 13, 20 | |
| FFA (free fatty acid) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinne FOURMY, MD | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Amiens | Amiens | France | ||||
| Clinical Research Center University Hospital Caen |
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| UNKNOWN |
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| electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week | Device | outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA) |
|
| Week 0, 6, 13, 20 |
| IL6 (interleukin 6) | Week 0, 6, 13, 20 |
| TNFalpha | Week 0, 6, 13, 20 |
| adiponectin | Week 0, 6, 13, 20 |
| CRPus (C Reactive Protein ultra sensitive) | Week 0, 6, 13, 20 |
| irisin | Week 0, 6, 13, 20 |
| satisfaction questionnaire | Week 0, 6, 13, 20 |
| motivation questionnaire for physical activity | Week 0, 6, 13, 20 |
| cardiometabolic stress test | Week 6, 20 |
| Caen |
| 14033 |
| France |
| University Hospital Lille | Lille | France |
| General Hospital Roubaix | Roubaix | France |
| CHU Rouen | Rouen | 76000 | France |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
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