Type 2 DiabetesELECTRODIABNCT02510521

Effects of Neuro-myo-electrical Stimulation on Insulin Sensitivity in Patients With Type 2 Diabetes

A study testing acute muscle exercise by NMES, daily workout sequence with NMES in one week and rest situation in people with Type 2 Diabetes, run by University Hospital, Caen at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: acute muscle exercise by NMES, daily workout sequence with NMES in one week and rest situation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteFrance
Study dates: Feb 2012to Jun 2014
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women 18-75 years of age:
Type 2 diabetes,
in a context of overweight BMI upper than 25 kg / m²,
a glycated hemoglobin included between 6 and 9%,
treated with oral antidiabetic (non glitazone) and / or GLP1 analogs (stable treatment for 3 months).
Patient who signed informed consent.

Who cannot join

Type 1 diabetes
Children or adolescents under 18 years.
Patients over 75 years.
Pregnancy.
Patient intense practicing regular physical activity and do not wish to interrupt the time of the study
Patients with painful joint disease of the knee mobilization (osteoarthritis, inflammatory arthritis), any severe neuromuscular disease (diabetic neuropathy with pain, cramps, paresthesia, hypoesthesia, degenerative muscle disease).

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Patients with unstable ischemic heart disease or arterial disease severe lower limbs.
Presence of a pacemaker (pacemaker).
Epilepsy
Patients insulin applicants
Treatment with glitazone.
Sepsis or other intercurrent acute disease (heart attack, angina ..).
Patients with skin lesions of any kind (wounds, inflammations, burns, irritations, eczema, etc.) nearby with areas for electrodes NMES
Patients unable to comply with the safety instructions of the NMES device at home
Patient unable to submit to medical monitoring study for geographical, social or psychological.
Patients under guardianship or trusteeship.
Patient included in another biomedical research protocol

Trial locations and contacts

1 site in 1 country.

France1 site

Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
Caen, 14000

Other trials in France

About this study

Type 2 diabetes is a major public health problem because of its increasing prevalence and morbidity and mortality that accompanies it. Therapeutic management of this pathology, lifestyle measures, dietary and physical activity are fundamental. Their observance is unfortunately too often insufficient, leading to a therapeutic climbing with first oral antidiabetic (OAD) then the use of insulin therapy.

Yet there is now ample evidence that physical activity improves glucose control in these patients in particular improving insulin sensitivity after a training period but also after a single session of physical activity.

Neuro-myo-electrical stimulation (NMES) is used in common clinical practice in physical therapy, patients with neurological or after orthopedic surgery in particular. In fact, this method enables improvement of volume and strength, even for denervated muscles. Recent studies have also shown the benefits of NMES in situations of cardiac or respiratory readjustments. In addition, NMES is used by top athletes supplements classical training in order to develop muscle strength or speed recovery.

Investigators propose to test the impact of bilateral quadriceps NMES on insulin sensitivity in type 2 diabetic patients treated with OAD (excluding glitazone). To do this, investigators plan to assess their insulin sensitivity by the reference method of hyperinsulinemic euglycemic clamp before surgery, after a single session of bilateral quadriceps NMES and after a sequence of daily training 6 days a quadriceps NMES bilateral.

Investigators hope to show an improvement in insulin sensitivity by this method, which would constitute an alternative to physical activity in the treatment of diabetes type 2. This procedure would be particularly interesting in diabetic subjects with type 2 counter- indications or an inability to perform a conventional physical activity.

Conditions: Type 2 Diabetes
Being tested: acute muscle exercise by NMES, daily workout sequence with NMES in one week, rest situation
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

acute muscle exercise by NMESDevice
daily workout sequence with NMES in one weekDevice
rest situationOther

Study groups in NCT02510521
Study group	Role	What they receive
in rest situation	Placebo comparator	No intervention during one week. Daily usual activities are allowed. Receives: Other: rest situation
after acute muscle exercise by NMES	Experimental	A working session of 20 minutes with three sequences electrostimulation: * warming-up sequence * work sequence (starting at 50% of the intensity achieved during warm-up) * relaxation sequence Electrostimulation relates both quadriceps are stimulated simultaneously and jointly. During the sessions, the patient sits on a chair or on a chair, legs bent at 90 °. So that there is no extension of the legs when electrostimulation (which could be painful), a strap is placed behind the legs of the chair or armchair and holds the pegs. Receives: Device: acute muscle exercise by NMES
after a daily workout sequence with NMES in one week	Experimental	Working sessions of 20 minutes 7 days in a row, including : * warming-up sequence * work sequence (starting at 50% of the intensity achieved during warm-up) * relaxation sequence Electrostimulation relates both quadriceps are stimulated simultaneously and jointly. During the sessions, the patient sits on a chair or on a chair, legs bent at 90 °. So that there is no extension of the legs when electrostimulation (which could be painful), a strap is placed behind the legs of the chair or armchair and holds the pegs. Receives: Device: daily workout sequence with NMES in one week

What is being measured

The primary outcome is the main question the study is designed to answer.

insulin sensitivity measured by the reference euglycemic hyperinsulinemic clamp technique
Measured: change over time : baseline, week 1, end of week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Jun 2014

First posted29 Jul 2015 (estimated)
Study startFeb 2012
Primary completionJun 2013
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by University Hospital, CaenThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02510521
Sponsor's protocol ID: 11-063
Acronym: ELECTRODIAB
Status last verified: Nov 2015
First submitted: 23 Jul 2015
Last updated: 2 Apr 2026
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 25107502

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Neuro-myo-electrical Stimulation on Insulin Sensitivity in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT02510521
Acronym / sponsor ID: ELECTRODIAB / 11-063
Conditions: Type 2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University Hospital, CaenUniversity, hospital or other
Study start: Feb 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2014 (actual)
First posted: 29 Jul 2015 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
in rest situation	Placebo comparator	Other: rest situationNo intervention during one week. Daily usual activities are allowed.
after acute muscle exercise by NMES	Experimental	Device: acute muscle exercise by NMESA working session of 20 minutes with three sequences electrostimulation: * warming-up sequence * work sequence (starting at 50% of the intensity achieved during warm-up) * relaxation sequence Electrostimulation relates both quadriceps are stimulated simultaneously and jointly. During the sessions, the patient sits on a chair or on a chair, legs bent at 90 °. So that there is no extension of the legs when electrostimulation (which could be painful), a strap is placed behind the legs of the chair or armchair and holds the pegs.
after a daily workout sequence with NMES in one week	Experimental	Device: daily workout sequence with NMES in one weekWorking sessions of 20 minutes 7 days in a row, including : * warming-up sequence * work sequence (starting at 50% of the intensity achieved during warm-up) * relaxation sequence Electrostimulation relates both quadriceps are stimulated simultaneously and jointly. During the sessions, the patient sits on a chair or on a chair, legs bent at 90 °. So that there is no extension of the legs when electrostimulation (which could be painful), a strap is placed behind the legs of the chair or armchair and holds the pegs.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Men and women 18-75 years of age:
Type 2 diabetes,
in a context of overweight BMI upper than 25 kg / m²,
a glycated hemoglobin included between 6 and 9%,
treated with oral antidiabetic (non glitazone) and / or GLP1 analogs (stable treatment for 3 months).

Key exclusion criteria (17 listed)

Type 1 diabetes
Children or adolescents under 18 years.
Patients over 75 years.
Pregnancy.
Patient intense practicing regular physical activity and do not wish to interrupt the time of the study

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
acute muscle exercise by NMES	Device	after acute muscle exercise by NMES
daily workout sequence with NMES in one week	Device	after a daily workout sequence with NMES in one week
rest situation	Other	in rest situation

Primary outcome

insulin sensitivity measured by the reference euglycemic hyperinsulinemic clamp technique
Time frame: change over time : baseline, week 1, end of week 2

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 2 Apr 2026.
Results publication: 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.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
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Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing acute muscle exercise by NMES, daily workout sequence with NMES in one week and rest situation in people with Type 2 Diabetes, run by University Hospital, Caen 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 6 inclusion and 17 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 2 Apr 2026. 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. Some participants in this study may receive a placebo. 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?

insulin sensitivity measured by the reference euglycemic hyperinsulinemic clamp technique (time frame: change over time : baseline, week 1, end of week 2). 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 NCT02510521, which also lists 1 linked publication.

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 2 Apr 2026.