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ELECTRODIAB2
ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.
Sponsor study identifier
interventional
38
1 country
5
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2022
Actual (reported)Study Completion
July 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 19, 2014
Actual (reported)June 6, 2014
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 2022
Actual (reported)July 2022
Actual (reported)Mean CGM glucose from a 6-day CGM recording
week 0, 6, 13, 20
HbA1c
week 0, 6, 13, 20
fasting plasma glucose
Week 0, 6, 13, 20
fasting plasma insulin
Week 0, 6, 13, 20
FFA (free fatty acid)
Week 0, 6, 13, 20
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
outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2\* (DJO, Vista, CA, USA)
outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2\* (DJO, Vista, CA, USA)
University Hospital Amiens
Amiens, France
Clinical Research Center University Hospital Caen
Caen, 14033, France
University Hospital Lille
Lille, France
General Hospital Roubaix
Roubaix, France
CHU Rouen
Rouen, 76000, France
Corinne FOURMY, MD
University Hospital, Caen
38 participants (actual enrollment reported by the registry).
First Submitted
May 19, 2014
First Posted
June 6, 2014
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
July 2022
Actual (reported)Study Completion
July 2022
Actual (reported)Last Updated
August 24, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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