Clinical trial NCT04643899: Effects of Electrostimulation on Glycemic Control in Obesity
Official title: Evaluation of the Effects of Electrical Muscle Stimulation on Carbohydrate Homeostasis in Adult Patients With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Adult Onset
Keywords: muscle electrostimulation
diabetes
endocrinology
physical activity
quality of life
obesity
Lead sponsor: Fondation Ildys
Sponsor class: OTHER
Collaborators: name: Lille Catholic University
First posted: 2020-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Monocentric; prospective; opened ; randomized; controlled study
* Distribution of patients in groups according to a ratio (1: 1)
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Carbohydrate balance
timeFrame: Continuous measurement over the entire stay (Day 1 to Day 21)
Secondary outcomes:
measure: Homa Index
timeFrame: Change from baseline (Day 1) to week 3 (Day 21)
measure: Quicki Index
timeFrame: Change from baseline (Day 1) to week 3 (Day 21)
measure: Blood Glucose Levels
timeFrame: Continuous measurement over the entire stay (Day 1 to Day 21)
measure: Postprandial blood glucose
timeFrame: Continuous measurement over the entire stay (Day 1 to Day 21)
measure: Basal blood metabolism
timeFrame: Change from baseline (Day 2) to week 3 (Day 21)
measure: Impedance
timeFrame: Change from baseline (Day 2) to week 3 (Day 20)
measure: Maximal voluntary force
timeFrame: Change from baseline (Day 2) to week 3 (Day 21)
measure: Six-minutes walk test (6MWT)
timeFrame: Change from baseline (Day 1) to week 3 (Day 20)
measure: "Ricci & Gagnon" questionnaire
timeFrame: Change from baseline (Day 2) to week 3 (Day 21)
measure: Adherence to the rehabilitation program
timeFrame: Evaluation at each sessions from Day 1 to Day 21
measure: Anthropometry
timeFrame: Change from baseline (Day 1) to week 3 (Day 21)
measure: Quality of life, obesity and dietetics (QOLOD) rating scale
timeFrame: Change from baseline (Day 1) to week 3 (Day 21)
measure: Visual analog pain scale
timeFrame: Evaluation at each sessions from Day 2 to Day 20
measure: MES sessions check
timeFrame: Change from baseline (Day 1) to week 3 (Day 21)
Other outcomes:
Locations:
city: Roscoff
country: France
facility: CF Center - Fondation Ildys Site de Perharidy
Study officials:
affiliation: Fondation Ildys
name: Lena SEITE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grosset JF, Crowe L, De Vito G, O'Shea D, Caulfield B. Comparative effect of a 1 h session of electrical muscle stimulation and walking activity on energy expenditure and substrate oxidation in obese subjects. Appl Physiol Nutr Metab. 2013 Jan;38(1):57-65. doi: 10.1139/apnm-2011-0367. Epub 2012 Nov 12.
citation: van Buuren F, Horstkotte D, Mellwig KP, Frund A, Vlachojannis M, Bogunovic N, Dimitriadis Z, Vortherms J, Humphrey R, Niebauer J. Electrical Myostimulation (EMS) Improves Glucose Metabolism and Oxygen Uptake in Type 2 Diabetes Mellitus Patients--Results from the EMS Study. Diabetes Technol Ther. 2015 Jun;17(6):413-9. doi: 10.1089/dia.2014.0315. Epub 2015 Mar 3.
citation: Joubert M, Metayer L, Prevost G, Morera J, Rod A, Cailleux A, Parienti JJ, Reznik Y. Neuromuscular electrostimulation and insulin sensitivity in patients with type 2 diabetes: the ELECTRODIAB pilot study. Acta Diabetol. 2015 Apr;52(2):285-91. doi: 10.1007/s00592-014-0636-5. Epub 2014 Aug 9.
citation: Miyamoto T, Fukuda K, Kimura T, Matsubara Y, Tsuda K, Moritani T. Effect of percutaneous electrical muscle stimulation on postprandial hyperglycemia in type 2 diabetes. Diabetes Res Clin Pract. 2012 Jun;96(3):306-12. doi: 10.1016/j.diabres.2012.01.006. Epub 2012 Jan 30.
citation: Vivodtzev I, Maffiuletti NA, Borel AL, Grangier A, Wuyam B, Tamisier R, Pepin JL. Acute Feasibility of Neuromuscular Electrical Stimulation in Severely Obese Patients with Obstructive Sleep Apnea Syndrome: A Pilot Study. Biomed Res Int. 2017;2017:3704380. doi: 10.1155/2017/3704380. Epub 2017 Jan 17.