Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes

NCT ID: NCT02157480

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2022-07-31

Brief Summary

Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the cornerstone treatment for patients with T2D who are often overweight and sedentary.

Physical activity improves glucose metabolism of patients with T2D : increased glucose utilization during acute muscle activity and improved insulin sensitivity after regular training. The molecular mechanism underlying the effects of exercise on glucose metabolism involves the glucose transporter GLUT-4 which is regulated by physical activity.

Several studies and meta-analysis have showed that physical activity reduces HbA1c by 0.6% on average. In addition, other data suggest a decrease in cardiovascular morbidity and mortality through physical activity.

Recent recommendations for T2D management call for the practice of a structured type of endurance 150 minutes per week and muscle building 2 times per week. However, implementation of these recommendations is low, even when integrated into a therapeutic education program. Adherence is often transient and / or partial. In addition, many T2D subjects are unable to initiate a physical activity because of disabling complications or comorbidities or because of a major cardiorespiratory deconditioning.

Neuro-myo electrical stimulation (NMES) is a physical treatment routinely used in functional rehabilitation to improve muscle strength and volume. The metabolic effect of NMES has been little studied. A pilot study conducted by our team on a population of 18 subjects with T2D showed that a week of daily NMES sessions significantly improved insulin sensitivity of about 25% and up to 50 % for good responders. This result contrasted with the low induced energy expenditure by each 20-minute session of bi-quadricipital NMES, suggesting the possibility of a humoral or neural mechanism associated with NMES.

To complete this work, we plan a randomized cross-over trial with 3 periods (6 weeks without NMES (control), 6 weeks with 3 sessions of NMES per week and 6 weeks with 5 sessions of NMES per week) to assess the glucose profile of sedentary T2D subjects during these different periods. We hypothesize that the bi-quadricipital NMES could improve glycemic control in T2D subjects and thus represent an alternative to traditional physical activity.

Conditions

Type 2 Diabetes; Physical Activity

Study Design

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

Study Groups

electrostimulation 5 days per week

20 minutes ambulatory bi-quadricipital electrostimulation sessions five times per week for 6 weeks

Group Type: EXPERIMENTAL

electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week

Intervention Type: DEVICE

outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2\* (DJO, Vista, CA, USA)

control

usual follow-up for 6 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

electrostimulation 3 days per week

20 minutes ambulatory bi-quadricipital electrostimulation sessions three times per week for 6 weeks

Group Type: EXPERIMENTAL

electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .

Intervention Type: DEVICE

outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2\* (DJO, Vista, CA, USA)

Interventions

electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .

outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2\* (DJO, Vista, CA, USA)

Intervention Type: DEVICE

electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week

outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2\* (DJO, Vista, CA, USA)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Type 2 diabetes treated with lifestyle, oral hypoglycemic agents and/or GLP-1 agonists.
• HbA1c : 7 to 10%
• low physical activity (Ricci and Gagnon score below 27)
• Insulin-resistance (at least one criteria out three):
• Waist circumference > 80cm in women and > 94cm in men
• Triglycerides > 150 mg/dl
• HDL-c < 50 mg/dl for women, < 40 mg/dl for men

Exclusion Criteria

• type 1 diabetes
• pregnancy
• intense usual physical activity
• pace maker
• seizure
• knee or neuromuscular pathology

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: collaborator

Amiens University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: collaborator

General Hospital Roubaix

UNKNOWN

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corinne FOURMY, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

University Hospital Amiens

Amiens, , France

Clinical Research Center University Hospital Caen

Caen, , France

University Hospital Lille

Lille, , France

General Hospital Roubaix

Roubaix, , France

CHU Rouen

Rouen, , France

Countries

France

Other Identifiers

2014-A00231-46

Identifier Type: -

Identifier Source: org_study_id