Effects of Electrostimulation on Glycemic Control in Obesity

Study Overview
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Brief Summary
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This study evaluate the effects of muscle electrostimulation (MES) on carbohydrate homeostasis in adult patients with obesity. Its aims are also to evaluate the tolerance of feasibilty and the tolerance of MES and the impact on basal metabolism ; muscle mass (maintenance, gain or loss) in a context of calorie restriction ; physical capacities ; adherence to the usual rehabilitation program ; eating behavior : quality of life.

Detailed Description
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Prevalence of adult obesity in general french population (≈15%) justifies the implementation of innovative care. Prescribing regular physical activity is one of the recommendations for managing obesity. However, patients find it difficult because of non-adapted offered activities; non-achievement concrete results despite the effort; difficulties to manage activities and to plan objective. Situation is seen as a failure and discourages patients. In addition, the obese patient may suffer from orthopedic disorders, cardiovascular contraindications, and the excessive weight in itself may force him to become sedentary. The recommendations on the practice of physical activity in the overall management of obesity are therefore not always applicable. Muscle electrostimulation (MES) could therefore be an interesting additional tool in the management of obesity and particularly of glycemic control in obese patients suffering from type 2 diabetes. Studies are still relatively few and present certain limits (small samples, short period of MES, very specific populations, few parameters evaluated, lack of consensus on the methods of MES, etc.). The results are nevertheless encouraging and call for the implementation of additional studies. Investigators therefore propose a controlled, randomized, single-center study in a group of 60 adult patients suffering from severe or morbid obesity (BMI> = 35) in a 3-week rehabilitation stay. The aims are to establish whether MES is a possible and interesting tool in the management of obesity, by checking the following hypotheses: control of carbohydrate metabolism is better when a MES is implemented; MES sessions improve patients' physical capacities and / or their tolerance to exercise; MES improves the quality of life of patients; MES improves patient adherence to the usual nutritional rehabilitation program; MES sessions are well tolerated and the accepted intensity nevertheless guarantees sufficient muscle stimulation.

Official Title
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Evaluation of the Effects of Electrical Muscle Stimulation on Carbohydrate Homeostasis in Adult Patients With Obesity

Conditions
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Obesity Adult Onset

Intervention / Treatment
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* Device: Muscle Electrostimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women over 18 years old and under 70 years old with severe or morbid obesity (BMI> = 35) with or without bariatric surgery able to understand and respect the protocol and its requirement who signed the consent prior to any other procedure protocol Exclusion Criteria: major patients under guardianship / curatorship / legal protection pregnant patients patients with epilepsy with an implanted electronic/electrical device (cardiac pacemaker, intracardiac defibrillator, etc.) with a baclofen pump suffering from serious disorders of the arterial circulation in the lower limbs such as Peripheral Arterial Obstructive Disease (PAOD) suffering from abdominal or inguinal hernia suffering from cardiac arrhythmia suffering from skin lesions and/or infections foci on one or more areas where the electrodes are placed suffering from sensory disorders in the areas of stimulation patients unable to complete the entire program

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Monocentric; prospective; opened ; randomized; controlled study Distribution of patients in groups according to a ratio (1: 1)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Patients benefiting only from the usual nutritional rehabilitation program G1a: diabetic patients G1b: non-diabetic patients | |
| Experimental: Electrostimulation group<br>Patients benefiting from the usual program AND muscle electrostimulation sessions G2a: diabetic patients G2b: non-diabetic patients | Device: Muscle Electrostimulation<br>* Scheduled sessions of 20 minutes per day; 5 days a week In physiotherapy or in their room for the most dependent patients Installation and monitoring by a physiotherapist or by the trained clinical research nurse Modalities: Device program n ° 1: 20mn (2mn of warm-up, 15mn of work at 75hz, then 3mn of recovery) 4 electrodes (2 per thigh): large model (5 * 10 cm) for better comfort - Dura-Stick Plus model (reference 42200) Gradual auto-increase of the intensity to the highest possible value tolerated, nevertheless allowing a contraction<br>* Other names: 253311x - REF 201010;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbohydrate balance | Evaluation of the time spent (%) above / in / below the patient's glycemic targets measured with a Free Style glycemic holter | Continuous measurement over the entire stay (Day 1 to Day 21) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homa Index | Insulin resistance assessment | Change from baseline (Day 1) to week 3 (Day 21) | 
| Quicki Index | Insulin sensitivity assessment | Change from baseline (Day 1) to week 3 (Day 21) | 
| Blood Glucose Levels | Evaluation of the glucose levels (average, minimum, maximum) | Continuous measurement over the entire stay (Day 1 to Day 21) | 
| Postprandial blood glucose | Assessment of the number of postprandial hyper and hypoglycemia | Continuous measurement over the entire stay (Day 1 to Day 21) | 
| Basal blood metabolism | Blood chemistry analysis (lipid balance) | Change from baseline (Day 2) to week 3 (Day 21) | 
| Impedance | Bioelectrical impedance analysis of body composition | Change from baseline (Day 2) to week 3 (Day 20) | 
| Maximal voluntary force | Measurement of the maximum voluntary strength and endurance of the quadriceps | Change from baseline (Day 2) to week 3 (Day 21) | 
| Six-minutes walk test (6MWT) | Measurement of the distance traveled during the 6MWT | Change from baseline (Day 1) to week 3 (Day 20) | 
| Ricci & Gagnon questionnaire | Assessment of the level of physical activities and sedentary lifestyle | Change from baseline (Day 2) to week 3 (Day 21) | 
| Adherence to the rehabilitation program | Evaluation of the number of performed sessions compared to the expected for the proposed activities (collective balneotherapy, individual balneotherapy, supervised adapted physical activities, independent nordic walking) with analysis of the reasons for the differences | Evaluation at each sessions from Day 1 to Day 21 | 
| Anthropometry | Weight (Kg) and height (cm) will be combined to report BMI in kg/m2 | Change from baseline (Day 1) to week 3 (Day 21) | 
| Quality of life, obesity and dietetics (QOLOD) rating scale | Evaluation of quality of life - This scale gives 5 sub-scores ranging from 0 (worse outcome) to 100 (better outcome) for each explored dimension. | Change from baseline (Day 1) to week 3 (Day 21) | 
| Visual analog pain scale | Assessment of pain intensity during MES sessions with a visual analog scale | Evaluation at each sessions from Day 2 to Day 20 | 
| MES sessions check | Record of session criteria (duration, program, maximum intensity, contraction Y/N) | Change from baseline (Day 1) to week 3 (Day 21) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle electrostimulation, diabetes, endocrinology, physical activity, quality of life, obesity