Effects of Electrostimulation on Glycemic Control in Obesity (ElectrOBA)
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|ClinicalTrials.gov Identifier: NCT04643899|
Recruitment Status : Not yet recruiting
First Posted : November 25, 2020
Last Update Posted : November 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obesity Adult Onset||Device: Muscle Electrostimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Effects of Electrical Muscle Stimulation on Carbohydrate Homeostasis in Adult Patients With Obesity|
|Estimated Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||September 1, 2022|
|Estimated Study Completion Date :||June 1, 2023|
No Intervention: Control group
Patients benefiting only from the usual nutritional rehabilitation program G1a: diabetic patients G1b: non-diabetic patients
Experimental: Electrostimulation group
Patients benefiting from the usual program AND muscle electrostimulation sessions G2a: diabetic patients G2b: non-diabetic patients
Device: Muscle Electrostimulation
- Carbohydrate balance [ Time Frame: Continuous measurement over the entire stay (Day 1 to Day 21) ]Evaluation of the time spent (%) above / in / below the patient's glycemic targets measured with a "Free Style" glycemic holter
- Homa Index [ Time Frame: Change from baseline (Day 1) to week 3 (Day 21) ]Insulin resistance assessment
- Quicki Index [ Time Frame: Change from baseline (Day 1) to week 3 (Day 21) ]Insulin sensitivity assessment
- Blood Glucose Levels [ Time Frame: Continuous measurement over the entire stay (Day 1 to Day 21) ]Evaluation of the glucose levels (average, minimum, maximum)
- Postprandial blood glucose [ Time Frame: Continuous measurement over the entire stay (Day 1 to Day 21) ]Assessment of the number of postprandial hyper and hypoglycemia
- Basal blood metabolism [ Time Frame: Change from baseline (Day 2) to week 3 (Day 21) ]Blood chemistry analysis (lipid balance)
- Impedance [ Time Frame: Change from baseline (Day 2) to week 3 (Day 20) ]Bioelectrical impedance analysis of body composition
- Maximal voluntary force [ Time Frame: Change from baseline (Day 2) to week 3 (Day 21) ]Measurement of the maximum voluntary strength and endurance of the quadriceps
- Six-minutes walk test (6MWT) [ Time Frame: Change from baseline (Day 1) to week 3 (Day 20) ]Measurement of the distance traveled during the 6MWT
- "Ricci & Gagnon" questionnaire [ Time Frame: Change from baseline (Day 2) to week 3 (Day 21) ]Assessment of the level of physical activities and sedentary lifestyle
- Adherence to the rehabilitation program [ Time Frame: Evaluation at each sessions from Day 1 to Day 21 ]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
- Anthropometry [ Time Frame: Change from baseline (Day 1) to week 3 (Day 21) ]Weight (Kg) and height (cm) will be combined to report BMI in kg/m2
- Quality of life, obesity and dietetics (QOLOD) rating scale [ Time Frame: Change from baseline (Day 1) to week 3 (Day 21) ]Evaluation of quality of life - This scale gives 5 sub-scores ranging from 0 (worse outcome) to 100 (better outcome) for each explored dimension.
- Visual analog pain scale [ Time Frame: Evaluation at each sessions from Day 2 to Day 20 ]Assessment of pain intensity during MES sessions with a visual analog scale
- MES sessions check [ Time Frame: Change from baseline (Day 1) to week 3 (Day 21) ]Record of session criteria (duration, program, maximum intensity, contraction Y/N)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643899
|Contact: Laetitia GUEGANTON, PhDfirstname.lastname@example.org|
|Contact: Marion BUYSE, MDemail@example.com|
|CF Center - Fondation Ildys Site de Perharidy|
|Roscoff, France, 29684|
|Principal Investigator:||Lena SEITE, MD||Fondation Ildys|