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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02171351
Acronym
ELECTROSYMP2
Enrollment
0
Registered
2014-06-24
Start date
2020-08-01
Completion date
2022-06-30
Last updated
2022-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Type 2 Diabetes

Keywords

sympathetic nerve reactivity, neuromuscular electrostimulation

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.

Interventions

DEVICEeffect of neuromuscular electrostimulation (NMES)

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

DEVICEeffect of neuro electrostimulation (NES)

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

OTHEReffect of voluntary contractions (VC)

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

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sympathetic nerve reactivity in response to a single session of neuromuscular electrostimulationat 0, 5, 10, 15, 20 min of the NMES sessionSympathetic 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

Secondary

MeasureTime frameDescription
sympathetic nerve reactivity in response to a single session of neuro electrostimulationat 0, 5, 10, 15, 20 min of the NES sessionSympathetic nerve reactivity will be assessed by plethysmography, with a Valsalva procedure, at baseline and every 5 minutes during a 20-min session of biquadricipital neuro electrostimulation
sympathetic nerve reactivity in response to a single session of voluntary muscular contractionsat 0, 5, 10, 15, 20 min of the VC sessionSympathetic nerve reactivity will be assessed by plethysmography, with a Valsalva procedure, at baseline and every 5 minutes during a 20-min session of biquadricipital voluntary contractions

Other

MeasureTime frameDescription
comparison of sympathetic nerve reactivity between the different groups and proceduresat 0, 5, 10, 15, 20 min of each sessionsympathetic nerve reactivity will be compared between type 2 diabetic and healthy subjects and between neuromuscular electrostimulation, neuro electrostimulation and voluntary contractions

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026