Clinical trial NCT02157480: Effect of Electrostimulation on Glucose Profile of Patients With Type 2 Diabetes
Official title: ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Physical Activity
Keywords: glucose profile
continuous glucose monitoring
electrostimulation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: University Hospital, Rouen
name: Amiens University Hospital
name: University Hospital, Lille
name: General Hospital Roubaix
First posted: 2014-06-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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
* seizure
* knee or neuromuscular pathology

Primary outcomes:
measure: Mean CGM glucose from a 6-day CGM recording
timeFrame: week 0, 6, 13, 20
Secondary outcomes:
measure: HbA1c
timeFrame: week 0, 6, 13, 20
Other outcomes:
measure: fasting plasma glucose
timeFrame: Week 0, 6, 13, 20
measure: fasting plasma insulin
timeFrame: Week 0, 6, 13, 20
measure: FFA (free fatty acid)
timeFrame: Week 0, 6, 13, 20
measure: IL6 (interleukin 6)
timeFrame: Week 0, 6, 13, 20
measure: TNFalpha
timeFrame: Week 0, 6, 13, 20
measure: adiponectin
timeFrame: Week 0, 6, 13, 20
measure: CRPus (C Reactive Protein ultra sensitive)
timeFrame: Week 0, 6, 13, 20
measure: irisin
timeFrame: Week 0, 6, 13, 20
measure: satisfaction questionnaire
timeFrame: Week 0, 6, 13, 20
measure: motivation questionnaire for physical activity
timeFrame: Week 0, 6, 13, 20
measure: cardiometabolic stress test
timeFrame: Week 6, 20
Locations:
city: Amiens
country: France
facility: University Hospital Amiens
city: Caen
country: France
facility: Clinical Research Center University Hospital Caen
city: Lille
country: France
facility: University Hospital Lille
city: Roubaix
country: France
facility: General Hospital Roubaix
city: Rouen
country: France
facility: CHU Rouen
Study officials:
affiliation: University Hospital, Caen
name: Corinne FOURMY, MD
role: PRINCIPAL_INVESTIGATOR
References: