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

March 30, 2026 updated by: University Hospital, Caen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: in rest situation
No intervention during one week. Daily usual activities are allowed.
Other: rest situation
Experimental: after acute muscle exercise by NMES

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.
Device: acute muscle exercise by NMES
Experimental: after a daily workout sequence with NMES in one week

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.
Device: daily workout sequence with NMES in one week

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimated)

July 29, 2015

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-063 (University of Pittsburgh Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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