Clinical trial NCT02171351: Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)
Official title: Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 2 Diabetes
Insulin Resistance
Keywords: sympathetic nerve reactivity
neuromuscular electrostimulation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Physical activity (PA) is recommended for the treatment of subjects with type 2 diabetes to increase insulin sensitivity and improve metabolic control. However, adherence to PA is often poor, due to a lack of motivation or due to disabling complications or comorbidities. Neuromuscular electrostimulation (NMES) is a physical treatment commonly used to improve muscle strength and volume in several situations: after stroke, after limb trauma or during chest rehabilitation in deconditioned patients. The investigators have already shown in a first pilot study (manuscript in preparation) that NMES improves insulin sensitivity : in the study ELECTRODIAB (No. ID-RCB: 2011-A00930-41), the investigators showed a 25% insulin sensitivity improvement after a week of daily 25-min bi-quadricipital NMES session, in a population of patients with orally-treated type 2 diabetes. Insulin sensitivity increased up to 50% in the most deconditioned subjects. Discrepancy between this result and the very low energy expenditure measured during sessions suggests that the metabolic effect was not solely mediated by muscle contractions. The investigators hypothesize the involvement of neurological pathways. Indeed, it is demonstrated that the autonomic nervous system is an important regulator of glucose metabolism with pancreatic action, a key role in energy metabolism and a complex relationship with insulin resistance. Muscle activity, whether static (isometric) or dynamic causes changes in sympathetic nerve activity in healthy subjects but its effect in type 2 diabetic subjects is not known. The investigators hypothesize that, in type 2 diabetic subjects, the modulation of sympathetic nerve activity by NMES could be involved in the improvement of insulin sensitivity. To address this question, the investigators propose to assess sympathetic nerve activity with the gold standard method of microneurography before and after a single bi-quadricipital NMES session. The impact of neuro-electro-stimulation (NES) (a sensitive stimulation under muscular threshold) and the impact of voluntary isometric muscle contractions (VC) will also be evaluated. These procedures will also be applied in healthy control subjects.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes for at least 12 month
* treatment by oral hypoglycemic agents and/or GLP1 agonists
* HbA1c : 6-10%
* suspected insulin-resistance (at least one criteria below) :
* waist circumference \> 80cm (female); \> 94cm (male)
* triglycerides \> 150 mg/dl
* HDL-cholesterol \< 50 mg/dl (female); \< 40 mg/dl (male)
* low background physical activity (Ricci-Gagnon score \< 27)

Exclusion Criteria:

* type 1 diabetes
* treatment with insulin
* seizure
* pace maker

Primary outcomes:
measure: Sympathetic nerve reactivity in response to a single session of neuromuscular electrostimulation
timeFrame: at 0, 5, 10, 15, 20 min of the NMES session
Secondary outcomes:
measure: sympathetic nerve reactivity in response to a single session of neuro electrostimulation
timeFrame: at 0, 5, 10, 15, 20 min of the NES session
measure: sympathetic nerve reactivity in response to a single session of voluntary muscular contractions
timeFrame: at 0, 5, 10, 15, 20 min of the VC session
Other outcomes:
measure: comparison of sympathetic nerve reactivity between the different groups and procedures
timeFrame: at 0, 5, 10, 15, 20 min of each session
Locations:
city: Caen
country: France
facility: Clinical Research Center Caen University Hospital
Study officials:
affiliation: University Hospital, Caen
name: Michael Joubert, MD
role: PRINCIPAL_INVESTIGATOR
References: