Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)

NCT ID: NCT02171351

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-06-30

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.

Conditions

Type 2 Diabetes; Insulin Resistance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

effect of neuromuscular electrostimulation (NMES)

Group Type: EXPERIMENTAL

effect of neuromuscular electrostimulation (NMES)

Intervention Type: DEVICE

Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuromuscular electrostimulation (NMES).

effect of neuro electrostimulation (NES)

Group Type: EXPERIMENTAL

effect of neuro electrostimulation (NES)

Intervention Type: DEVICE

Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuro electrostimulation (NES)

effect of voluntary contractions (VC)

Group Type: EXPERIMENTAL

effect of voluntary contractions (VC)

Intervention Type: OTHER

Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of voluntary contractions (VC)

Interventions

effect of neuromuscular electrostimulation (NMES)

Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuromuscular electrostimulation (NMES).

Intervention Type: DEVICE

effect of neuro electrostimulation (NES)

Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuro electrostimulation (NES)

Intervention Type: DEVICE

effect of voluntary contractions (VC)

Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of voluntary contractions (VC)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Joubert, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

Clinical Research Center Caen University Hospital

Caen, , France

Countries

France

Other Identifiers

2014-A00559-38

Identifier Type: -

Identifier Source: org_study_id