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

NCT ID: NCT02510521

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-06-30

Brief Summary

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

in rest situation

No intervention during one week. Daily usual activities are allowed.

Group Type: PLACEBO_COMPARATOR

rest situation

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

acute muscle exercise by NMES

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

daily workout sequence with NMES in one week

Intervention Type: DEVICE

Interventions

acute muscle exercise by NMES

Intervention Type: DEVICE

daily workout sequence with NMES in one week

Intervention Type: DEVICE

rest situation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Caen, , France

Countries

France

Other Identifiers

11-063

Identifier Type: -

Identifier Source: org_study_id