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Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)
ELECTROSYMP2
1 other identifier
interventional
N/A
1 country
1
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.
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Started Aug 2020
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2014
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedAugust 24, 2022
August 1, 2020
1.3 years
June 18, 2014
August 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sympathetic nerve reactivity in response to a single session of neuromuscular electrostimulation
Sympathetic nerve reactivity will be assessed by plethysmography, with a Valsalva procedure, at baseline and every 5 minutes during a 20-min session of biquadricipital neuromuscular electrostimulation
at 0, 5, 10, 15, 20 min of the NMES session
Secondary Outcomes (2)
sympathetic nerve reactivity in response to a single session of neuro electrostimulation
at 0, 5, 10, 15, 20 min of the NES session
sympathetic nerve reactivity in response to a single session of voluntary muscular contractions
at 0, 5, 10, 15, 20 min of the VC session
Other Outcomes (1)
comparison of sympathetic nerve reactivity between the different groups and procedures
at 0, 5, 10, 15, 20 min of each session
Study Arms (3)
effect of neuromuscular electrostimulation (NMES)
EXPERIMENTALeffect of neuro electrostimulation (NES)
EXPERIMENTALeffect of voluntary contractions (VC)
EXPERIMENTALInterventions
Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuromuscular electrostimulation (NMES).
Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuro electrostimulation (NES)
Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of voluntary contractions (VC)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- type 1 diabetes
- treatment with insulin
- seizure
- pace maker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Center Caen University Hospital
Caen, 14033, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Joubert, MD
University Hospital, Caen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2014
First Posted
June 24, 2014
Study Start
August 1, 2020
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
August 24, 2022
Record last verified: 2020-08