Physical Activity, Type 2 Diabetes
Conditions
Keywords
glucose profile, continuous glucose monitoring, electrostimulation
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.
Interventions
DEVICEelectrostimulation (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)
DEVICEelectrostimulation (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)
Sponsors
University Hospital, Rouen
Amiens University Hospital
University Hospital, Lille
General Hospital Roubaix
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean CGM glucose from a 6-day CGM recording | week 0, 6, 13, 20 |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c | week 0, 6, 13, 20 |
Other
| Measure | Time frame |
|---|---|
| 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 |
| adiponectin | Week 0, 6, 13, 20 |
| TNFalpha | Week 0, 6, 13, 20 |
| fasting plasma glucose | Week 0, 6, 13, 20 |
| fasting plasma insulin | Week 0, 6, 13, 20 |
| FFA (free fatty acid) | Week 0, 6, 13, 20 |
| IL6 (interleukin 6) | Week 0, 6, 13, 20 |
| CRPus (C Reactive Protein ultra sensitive) | Week 0, 6, 13, 20 |
Countries
France
Outcome results
None listed