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

NCT02510521 | Completed

• 1 other identifier: 11-063
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity measured by the reference euglycemic hyperinsulinemic clamp technique

  change over time : baseline, week 1, end of week 2

Study Arms (3)

in rest situation

PLACEBO COMPARATOR

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

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.

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.

Device: daily workout sequence with NMES in one week

Interventions

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

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

Caen, 14000, France

Location

Related Publications (1)

• 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.

  PMID: 25107502 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 29, 2015
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: April 2, 2026

Record last verified: 2015-11

Locations

FR (1)