Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes

NCT02157480 | Completed

• 1 other identifier: 2014-A00231-46
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 5

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.

Conditions

Type 2 Diabetes; Physical Activity

Keywords

glucose profile; continuous glucose monitoring; electrostimulation

Outcome Measures

Primary Outcomes (1)

• Mean CGM glucose from a 6-day CGM recording

  week 0, 6, 13, 20

Secondary Outcomes (1)

• HbA1c

  week 0, 6, 13, 20

Other Outcomes (11)

• 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

Study Arms (3)

control

NO INTERVENTION

usual follow-up for 6 weeks

electrostimulation 3 days per week

EXPERIMENTAL

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 .

electrostimulation 5 days per week

EXPERIMENTAL

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

Interventions

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 3 days per week

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)

electrostimulation 5 days per week

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• type 1 diabetes
• pregnancy
• intense usual physical activity
• pace maker
• seizure
• knee or neuromuscular pathology

Sponsors & Collaborators

• University Hospital, Caen: lead
• University Hospital, Rouen: collaborator
• Amiens University Hospital: collaborator
• University Hospital, Lille: collaborator
• General Hospital Roubaix: collaborator

Study Sites (5)

University Hospital Amiens

Amiens, France

Location

Clinical Research Center University Hospital Caen

Caen, 14033, France

Location

University Hospital Lille

Lille, France

Location

General Hospital Roubaix

Roubaix, France

Location

CHU Rouen

Rouen, 76000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Corinne FOURMY, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: June 6, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-07

Locations

FR (5)