NCT04643899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

October 29, 2020

Last Update Submit

September 12, 2023

Conditions

Obesity Adult Onset

Keywords

muscle electrostimulationdiabetesendocrinologyphysical activityquality of lifeobesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Homa Index

    Change from baseline (Day 1) to week 3 (Day 21)

  • Quicki Index

    Change from baseline (Day 1) to week 3 (Day 21)

  • Blood Glucose Levels

    Continuous measurement over the entire stay (Day 1 to Day 21)

  • Postprandial blood glucose

    Continuous measurement over the entire stay (Day 1 to Day 21)

  • Basal blood metabolism

    Change from baseline (Day 2) to week 3 (Day 21)

  • +9 more secondary outcomes

Study Arms (2)

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

Device: Muscle Electrostimulation

Interventions

Muscle ElectrostimulationDEVICE

* 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

Also known as: Compex Pro Rehab ®, 253311x - REF 201010
Electrostimulation group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CF Center - Fondation Ildys Site de Perharidy

Roscoff, 29684, France

Location

Related 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.

    PMID: 23368829BACKGROUND

  • 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.

    PMID: 25734937BACKGROUND

  • 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.

    PMID: 25107502BACKGROUND

  • 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.

    PMID: 22296854BACKGROUND

  • 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.

    PMID: 28194410BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusMotor ActivityObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lena SEITE, MD

    Fondation Ildys

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * Monocentric; prospective; opened ; randomized; controlled study * Distribution of patients in groups according to a ratio (1: 1)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 25, 2020

Study Start

March 29, 2021

Primary Completion

March 1, 2023

Study Completion

July 19, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)