Effects of Electrostimulation on Glycemic Control in Obesity

Obesity Adult Onset Clinical Trial

— ElectrOBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643899
• Other study ID #: ILDYS-ISC2-2020001
• Secondary ID: ID-RCB
• Status: Completed
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: July 19, 2023

Study information

• Verified date: September 2023
• Source: Fondation Ildys
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 19, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity Adult Onset

Intervention

Device:
• Muscle Electrostimulation
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

Locations

Country	Name	City	State
France	CF Center - Fondation Ildys Site de Perharidy	Roscoff

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ildys	Lille Catholic University

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Homa Index	Insulin resistance assessment	Change from baseline (Day 1) to week 3 (Day 21)
Secondary	Quicki Index	Insulin sensitivity assessment	Change from baseline (Day 1) to week 3 (Day 21)
Secondary	Blood Glucose Levels	Evaluation of the glucose levels (average, minimum, maximum)	Continuous measurement over the entire stay (Day 1 to Day 21)
Secondary	Postprandial blood glucose	Assessment of the number of postprandial hyper and hypoglycemia	Continuous measurement over the entire stay (Day 1 to Day 21)
Secondary	Basal blood metabolism	Blood chemistry analysis (lipid balance)	Change from baseline (Day 2) to week 3 (Day 21)
Secondary	Impedance	Bioelectrical impedance analysis of body composition	Change from baseline (Day 2) to week 3 (Day 20)
Secondary	Maximal voluntary force	Measurement of the maximum voluntary strength and endurance of the quadriceps	Change from baseline (Day 2) to week 3 (Day 21)
Secondary	Six-minutes walk test (6MWT)	Measurement of the distance traveled during the 6MWT	Change from baseline (Day 1) to week 3 (Day 20)
Secondary	"Ricci & Gagnon" questionnaire	Assessment of the level of physical activities and sedentary lifestyle	Change from baseline (Day 2) to week 3 (Day 21)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	MES sessions check	Record of session criteria (duration, program, maximum intensity, contraction Y/N)	Change from baseline (Day 1) to week 3 (Day 21)

External Links

•   National survey (France) on obesity and overweight