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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University Hospital, Caen
Sponsor:
Collaborators:
University Hospital, Rouen
Amiens University Hospital
University Hospital, Lille
General Hospital Roubaix
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT02157480
First received: May 19, 2014
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Physical Activity
Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .
Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Mean CGM glucose from a 6-day CGM recording [ Time Frame: week 0, 6, 13, 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: week 0, 6, 13, 20 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • fasting plasma glucose [ Time Frame: Week 0, 6, 13, 20 ] [ Designated as safety issue: No ]
  • fasting plasma insulin [ Time Frame: Week 0, 6, 13, 20 ] [ Designated as safety issue: No ]
  • FFA (free fatty acid) [ Time Frame: Week 0, 6, 13, 20 ] [ Designated as safety issue: No ]
  • IL6 (interleukin 6) [ Time Frame: Week 0, 6, 13, 20 ] [ Designated as safety issue: No ]
  • TNFalpha [ Time Frame: Week 0, 6, 13, 20 ] [ Designated as safety issue: No ]
  • adiponectin [ Time Frame: Week 0, 6, 13, 20 ] [ Designated as safety issue: No ]
  • CRPus (C Reactive Protein ultra sensitive) [ Time Frame: Week 0, 6, 13, 20 ] [ Designated as safety issue: No ]
  • irisin [ Time Frame: Week 0, 6, 13, 20 ] [ Designated as safety issue: No ]
  • satisfaction questionnaire [ Time Frame: Week 0, 6, 13, 20 ] [ Designated as safety issue: No ]
  • motivation questionnaire for physical activity [ Time Frame: Week 0, 6, 13, 20 ] [ Designated as safety issue: No ]
  • cardiometabolic stress test [ Time Frame: Week 6, 20 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: June 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .
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
Device: electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week
outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02157480

Contacts
Contact: Michael JOUBERT, MD +33231064575 joubert-m@chu-caen.fr

Locations
France
University Hospital Amiens Not yet recruiting
Amiens, France
Contact: Rachel DESAILLOUD         
Clinical Research Center University Hospital Caen Not yet recruiting
Caen, France, 14033
Contact: Sylvie BRUCATO, PhD    +33231065227    brucato-s@chu-caen.fr   
University Hospital Lille Not yet recruiting
Lille, France
Contact: Pierre FONTAINE, MD         
General Hospital Roubaix Not yet recruiting
Roubaix, France
Contact: Catherine FERMON         
Sponsors and Collaborators
University Hospital, Caen
University Hospital, Rouen
Amiens University Hospital
University Hospital, Lille
General Hospital Roubaix
Investigators
Principal Investigator: Corinne FOURMY, MD University Hospital, Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02157480     History of Changes
Other Study ID Numbers: 2014-A00231-46
Study First Received: May 19, 2014
Last Updated: June 10, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Caen:
glucose profile
continuous glucose monitoring
electrostimulation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014