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Clinical Trials/NCT02157480
NCT02157480
Completed
Not Applicable

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

University Hospital, Caen5 sites in 1 country38 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
University Hospital, Caen
Enrollment
38
Locations
5
Primary Endpoint
Mean CGM glucose from a 6-day CGM recording
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
July 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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
  • knee or neuromuscular pathology

Outcomes

Primary Outcomes

Mean CGM glucose from a 6-day CGM recording

Time Frame: week 0, 6, 13, 20

Secondary Outcomes

  • HbA1c(week 0, 6, 13, 20)

Study Sites (5)

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