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

Type 2 Diabetes Clinical Trial

— ELECTRODIAB  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510521
• Other study ID #: 11-063
• Status: Completed
• Phase: N/A
• First received: July 23, 2015
• Last updated: November 2, 2015
• Start date: February 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• acute muscle exercise by NMES

• daily workout sequence with NMES in one week

Other:
• rest situation

Locations

Country	Name	City	State
France	Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity measured by the reference euglycemic hyperinsulinemic clamp technique		change over time : baseline, week 1, end of week 2	No