Effects of Electrostimulation on Glycemic Control in Obesity (ElectrOBA)

Fondation Ildys

Status

Completed

Conditions

Obesity Adult Onset

Treatments

Device: Muscle Electrostimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04643899

ILDYS-ISC2-2020001

ID-RCB (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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