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Completed

NCT Number: NCT02157480

Effect of Electrostimulation on Glucose Profile of 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .

Device

outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)

electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week

Device

outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)

Primary outcomes

  1. Mean CGM glucose from a 6-day CGM recording

    Time frame: week 0, 6, 13, 20

Secondary outcomes

  1. HbA1c

    Time frame: week 0, 6, 13, 20

Other outcomes

  1. fasting plasma glucose

    Time frame: Week 0, 6, 13, 20

  2. fasting plasma insulin

    Time frame: Week 0, 6, 13, 20

  3. FFA (free fatty acid)

    Time frame: Week 0, 6, 13, 20

  4. IL6 (interleukin 6)

    Time frame: Week 0, 6, 13, 20

  5. TNFalpha

    Time frame: Week 0, 6, 13, 20

  6. adiponectin

    Time frame: Week 0, 6, 13, 20

  7. CRPus (C Reactive Protein ultra sensitive)

    Time frame: Week 0, 6, 13, 20

  8. irisin

    Time frame: Week 0, 6, 13, 20

  9. satisfaction questionnaire

    Time frame: Week 0, 6, 13, 20

  10. motivation questionnaire for physical activity

    Time frame: Week 0, 6, 13, 20

  11. cardiometabolic stress test

    Time frame: Week 6, 20

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Amiens University Hospital
  • General Hospital Roubaix
  • University Hospital, Lille
  • University Hospital, Rouen

Registry information

Official study title

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

Acronym: ELECTRODIAB2

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jun 6, 2014
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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