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

NCT02157480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-08-24

No results posted yet for this study

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

Interventions

DEVICE

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)

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)

Sponsors & Collaborators

  • University Hospital, Rouen

    collaborator OTHER
  • Amiens University Hospital

    collaborator OTHER
  • University Hospital, Lille

    collaborator OTHER
  • General Hospital Roubaix

    collaborator UNKNOWN
  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Corinne FOURMY, MD · University Hospital, Caen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02157480 on ClinicalTrials.gov