Obesity Adult OnsetElectrOBANCT04643899
Effects of Electrostimulation on Glycemic Control in Obesity
A study testing Muscle Electrostimulation in people with Obesity Adult Onset, run by Fondation Ildys at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity Adult Onset
- What is being tested?
- Muscle Electrostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2021to 19 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Electrical Muscle Stimulation on Carbohydrate Homeostasis in Adult Patients With Obesity
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.
Read the 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.
- Conditions
- Obesity Adult Onset
- Being tested
- Muscle Electrostimulation
- Keywords
- muscle electrostimulation, diabetes, endocrinology, physical activity, quality of life, obesity
- Medical subject headings
- Diabetes Mellitus, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle ElectrostimulationDevice
Also called Compex Pro Rehab ®, 253311x - REF 201010
- 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
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients benefiting only from the usual nutritional rehabilitation program G1a: diabetic patients G1b: non-diabetic patients |
| Electrostimulation group | Experimental | Patients benefiting from the usual program AND muscle electrostimulation sessions G2a: diabetic patients G2b: non-diabetic patients Receives: Device: Muscle Electrostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbohydrate balance
Evaluation of the time spent (%) above / in / below the patient's glycemic targets measured with a "Free Style" glycemic holter
Measured: Continuous measurement over the entire stay (Day 1 to Day 21)
Secondary outcomes (14)
Homa Index
Insulin resistance assessment
Measured: Change from baseline (Day 1) to week 3 (Day 21)
Quicki Index
Insulin sensitivity assessment
Measured: Change from baseline (Day 1) to week 3 (Day 21)
Blood Glucose Levels
Evaluation of the glucose levels (average, minimum, maximum)
Measured: Continuous measurement over the entire stay (Day 1 to Day 21)
Postprandial blood glucose
Assessment of the number of postprandial hyper and hypoglycemia
Measured: Continuous measurement over the entire stay (Day 1 to Day 21)
Basal blood metabolism
Blood chemistry analysis (lipid balance)
Measured: Change from baseline (Day 2) to week 3 (Day 21)
Impedance
Bioelectrical impedance analysis of body composition
Measured: Change from baseline (Day 2) to week 3 (Day 20)
Maximal voluntary force
Measurement of the maximum voluntary strength and endurance of the quadriceps
Measured: Change from baseline (Day 2) to week 3 (Day 21)
Six-minutes walk test (6MWT)
Measurement of the distance traveled during the 6MWT
Measured: Change from baseline (Day 1) to week 3 (Day 20)
"Ricci & Gagnon" questionnaire
Assessment of the level of physical activities and sedentary lifestyle
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Evaluation at each sessions from Day 2 to Day 20
MES sessions check
Record of session criteria (duration, program, maximum intensity, contraction Y/N)
Measured: Change from baseline (Day 1) to week 3 (Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start29 Mar 2021
- Primary completion1 Mar 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obesity Adult OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Monocentric; prospective; opened ; randomized; controlled study * Distribution of patients in groups according to a ratio (1: 1)
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ildys
- Sponsor type
- University, hospital or other
- Collaborators
- Lille Catholic University
- Responsible party
- Sponsor
- Investigators
- Lena SEITE, MD, Principal investigator, Fondation Ildys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643899
- Sponsor's protocol ID
- ILDYS-ISC2-2020001
- Other IDs
- ID-RCB
- Acronym
- ElectrOBA
- Status last verified
- Sep 2023
- First submitted
- 29 Oct 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23368829van 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.
PubMed 25734937Joubert 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.
PubMed 25107502Miyamoto 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.
PubMed 22296854Vivodtzev 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.
PubMed 28194410
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Electrical Muscle Stimulation on Carbohydrate Homeostasis in Adult Patients With Obesity
- ClinicalTrials.gov ID
- NCT04643899
- Acronym / sponsor ID
- ElectrOBA / ILDYS-ISC2-2020001
- Conditions
- Obesity Adult Onset
- Keywords
- muscle electrostimulation, diabetes, endocrinology, physical activity, quality of life, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondation IldysUniversity, hospital or other
- Collaborators
- Lille Catholic University
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Monocentric; prospective; opened ; randomized; controlled study * Distribution of patients in groups according to a ratio (1: 1)
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients benefiting only from the usual nutritional rehabilitation program G1a: diabetic patients G1b: non-diabetic patients |
| Electrostimulation group | Experimental | Device: Muscle ElectrostimulationPatients benefiting from the usual program AND muscle electrostimulation sessions G2a: diabetic patients G2b: non-diabetic patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle ElectrostimulationAlso: Compex Pro Rehab ®, 253311x - REF 201010* 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 | Device | Electrostimulation group |
Primary outcome
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
14 secondary outcomes
Homa Index
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Quicki Index
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Blood Glucose Levels
Time frame: Continuous measurement over the entire stay (Day 1 to Day 21)
Postprandial blood glucose
Time frame: Continuous measurement over the entire stay (Day 1 to Day 21)
Basal blood metabolism
Time frame: Change from baseline (Day 2) to week 3 (Day 21)
Impedance
Time frame: Change from baseline (Day 2) to week 3 (Day 20)
Maximal voluntary force
Time frame: Change from baseline (Day 2) to week 3 (Day 21)
Six-minutes walk test (6MWT)
Time frame: Change from baseline (Day 1) to week 3 (Day 20)
"Ricci & Gagnon" questionnaire
Time frame: Change from baseline (Day 2) to week 3 (Day 21)
Adherence to the rehabilitation program
Time frame: Evaluation at each sessions from Day 1 to Day 21
Anthropometry
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Quality of life, obesity and dietetics (QOLOD) rating scale
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Visual analog pain scale
Time frame: Evaluation at each sessions from Day 2 to Day 20
MES sessions check
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 23368829Grosset 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.
- Background: PubMed 25734937van 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.
- Background: PubMed 25107502Joubert 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.
- Background: PubMed 22296854Miyamoto 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.
- Background: PubMed 28194410Vivodtzev 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena SEITE, MD principal investigator
Fondation Ildys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Electrostimulation in people with Obesity Adult Onset, run by Fondation Ildys at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbohydrate balance (time frame: Continuous measurement over the entire stay (Day 1 to Day 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04643899, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.