- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02157480
Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes (ELECTRODIAB2)
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
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Corinne FOURMY, MD, University Hospital, Caen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A00231-46
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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