Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes (ELECTRODIAB2)
Primary Purpose
Type 2 Diabetes, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .
electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring glucose profile, continuous glucose monitoring, electrostimulation
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
Sites / Locations
- University Hospital Amiens
- Clinical Research Center University Hospital Caen
- University Hospital Lille
- General Hospital Roubaix
- CHU Rouen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
control
electrostimulation 3 days per week
electrostimulation 5 days per week
Arm Description
usual follow-up for 6 weeks
20 minutes ambulatory bi-quadricipital electrostimulation sessions three times per week for 6 weeks
20 minutes ambulatory bi-quadricipital electrostimulation sessions five times per week for 6 weeks
Outcomes
Primary Outcome Measures
Mean CGM glucose from a 6-day CGM recording
Secondary Outcome Measures
HbA1c
Full Information
NCT ID
NCT02157480
First Posted
May 19, 2014
Last Updated
August 23, 2022
Sponsor
University Hospital, Caen
Collaborators
University Hospital, Rouen, Amiens University Hospital, University Hospital, Lille, General Hospital Roubaix
1. Study Identification
Unique Protocol Identification Number
NCT02157480
Brief Title
Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes
Acronym
ELECTRODIAB2
Official Title
ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2022 (Actual)
Study Completion Date
July 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
University Hospital, Rouen, Amiens University Hospital, University Hospital, Lille, General Hospital Roubaix
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Physical Activity
Keywords
glucose profile, continuous glucose monitoring, electrostimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
usual follow-up for 6 weeks
Arm Title
electrostimulation 3 days per week
Arm Type
Experimental
Arm Description
20 minutes ambulatory bi-quadricipital electrostimulation sessions three times per week for 6 weeks
Arm Title
electrostimulation 5 days per week
Arm Type
Experimental
Arm Description
20 minutes ambulatory bi-quadricipital electrostimulation sessions five times per week for 6 weeks
Intervention Type
Device
Intervention Name(s)
electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .
Intervention Description
outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)
Intervention Type
Device
Intervention Name(s)
electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week
Intervention Description
outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)
Primary Outcome Measure Information:
Title
Mean CGM glucose from a 6-day CGM recording
Time Frame
week 0, 6, 13, 20
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
week 0, 6, 13, 20
Other Pre-specified Outcome Measures:
Title
fasting plasma glucose
Time Frame
Week 0, 6, 13, 20
Title
fasting plasma insulin
Time Frame
Week 0, 6, 13, 20
Title
FFA (free fatty acid)
Time Frame
Week 0, 6, 13, 20
Title
IL6 (interleukin 6)
Time Frame
Week 0, 6, 13, 20
Title
TNFalpha
Time Frame
Week 0, 6, 13, 20
Title
adiponectin
Time Frame
Week 0, 6, 13, 20
Title
CRPus (C Reactive Protein ultra sensitive)
Time Frame
Week 0, 6, 13, 20
Title
irisin
Time Frame
Week 0, 6, 13, 20
Title
satisfaction questionnaire
Time Frame
Week 0, 6, 13, 20
Title
motivation questionnaire for physical activity
Time Frame
Week 0, 6, 13, 20
Title
cardiometabolic stress test
Time Frame
Week 6, 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne FOURMY, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Amiens
City
Amiens
Country
France
Facility Name
Clinical Research Center University Hospital Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
University Hospital Lille
City
Lille
Country
France
Facility Name
General Hospital Roubaix
City
Roubaix
Country
France
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes
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