Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes (ELECTRODIAB2)

August 23, 2022 updated by: University Hospital, Caen

ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens, France
        • University Hospital Amiens
      • Caen, France, 14033
        • Clinical Research Center University Hospital Caen
      • Lille, France
        • University Hospital Lille
      • Roubaix, France
        • General Hospital Roubaix
      • Rouen, France, 76000
        • CHU Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
usual follow-up for 6 weeks
Experimental: electrostimulation 3 days per week
20 minutes ambulatory bi-quadricipital electrostimulation sessions three times per week for 6 weeks
outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)
Experimental: electrostimulation 5 days per week
20 minutes ambulatory bi-quadricipital electrostimulation sessions five times per week for 6 weeks
outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean CGM glucose from a 6-day CGM recording
Time Frame: week 0, 6, 13, 20
week 0, 6, 13, 20

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: week 0, 6, 13, 20
week 0, 6, 13, 20

Other Outcome Measures

Outcome Measure
Time Frame
fasting plasma glucose
Time Frame: Week 0, 6, 13, 20
Week 0, 6, 13, 20
fasting plasma insulin
Time Frame: Week 0, 6, 13, 20
Week 0, 6, 13, 20
FFA (free fatty acid)
Time Frame: Week 0, 6, 13, 20
Week 0, 6, 13, 20
IL6 (interleukin 6)
Time Frame: Week 0, 6, 13, 20
Week 0, 6, 13, 20
TNFalpha
Time Frame: Week 0, 6, 13, 20
Week 0, 6, 13, 20
adiponectin
Time Frame: Week 0, 6, 13, 20
Week 0, 6, 13, 20
CRPus (C Reactive Protein ultra sensitive)
Time Frame: Week 0, 6, 13, 20
Week 0, 6, 13, 20
irisin
Time Frame: Week 0, 6, 13, 20
Week 0, 6, 13, 20
satisfaction questionnaire
Time Frame: Week 0, 6, 13, 20
Week 0, 6, 13, 20
motivation questionnaire for physical activity
Time Frame: Week 0, 6, 13, 20
Week 0, 6, 13, 20
cardiometabolic stress test
Time Frame: Week 6, 20
Week 6, 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Corinne FOURMY, MD, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

July 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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