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

Primary Purpose

Type 2 Diabetes, Insulin Resistance

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
effect of neuromuscular electrostimulation (NMES)
effect of neuro electrostimulation (NES)
effect of voluntary contractions (VC)
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring sympathetic nerve reactivity, neuromuscular electrostimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Center Caen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

effect of neuromuscular electrostimulation (NMES)

effect of neuro electrostimulation (NES)

effect of voluntary contractions (VC)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

sympathetic nerve reactivity in response to a single session of neuro 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 neuro electrostimulation
sympathetic nerve reactivity in response to a single session of voluntary muscular contractions
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 voluntary contractions

Full Information

First Posted
June 18, 2014
Last Updated
August 23, 2022
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02171351
Brief Title
Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)
Acronym
ELECTROSYMP2
Official Title
Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Technical issue
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Insulin Resistance
Keywords
sympathetic nerve reactivity, neuromuscular electrostimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
effect of neuromuscular electrostimulation (NMES)
Arm Type
Experimental
Arm Title
effect of neuro electrostimulation (NES)
Arm Type
Experimental
Arm Title
effect of voluntary contractions (VC)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
effect of neuromuscular electrostimulation (NMES)
Intervention Description
Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuromuscular electrostimulation (NMES).
Intervention Type
Device
Intervention Name(s)
effect of neuro electrostimulation (NES)
Intervention Description
Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuro electrostimulation (NES)
Intervention Type
Other
Intervention Name(s)
effect of voluntary contractions (VC)
Intervention Description
Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of voluntary contractions (VC)
Primary Outcome Measure Information:
Title
Sympathetic nerve reactivity in response to a single session of neuromuscular electrostimulation
Description
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
Time Frame
at 0, 5, 10, 15, 20 min of the NMES session
Secondary Outcome Measure Information:
Title
sympathetic nerve reactivity in response to a single session of neuro electrostimulation
Description
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 neuro electrostimulation
Time Frame
at 0, 5, 10, 15, 20 min of the NES session
Title
sympathetic nerve reactivity in response to a single session of voluntary muscular contractions
Description
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 voluntary contractions
Time Frame
at 0, 5, 10, 15, 20 min of the VC session
Other Pre-specified Outcome Measures:
Title
comparison of sympathetic nerve reactivity between the different groups and procedures
Description
sympathetic nerve reactivity will be compared between type 2 diabetic and healthy subjects and between neuromuscular electrostimulation, neuro electrostimulation and voluntary contractions
Time Frame
at 0, 5, 10, 15, 20 min of each session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Joubert, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France

12. IPD Sharing Statement

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

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