CompletedNot Applicable

Effects of Electrostimulation on Glycemic Control in Obesity

France60 participantsStarted 2021-03-29

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Carbohydrate balance

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

Trial details

NCT IDNCT04643899

SponsorFondation Ildys

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-01

View on ClinicalTrials.gov More Obesity Adult Onset trials