Type 2 DiabetesELECTROSYMP2NCT02171351
Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)
A study testing effect of neuromuscular electrostimulation (NMES), effect of neuro electrostimulation (NES) and effect of voluntary contractions (VC) in people with Type 2 Diabetes and Insulin Resistance, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Insulin Resistance
- What is being tested?
- effect of neuromuscular electrostimulation (NMES), effect of neuro electrostimulation (NES) and effect of voluntary contractions (VC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- type 1 diabetes
- treatment with insulin
- seizure
- pace maker
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- effect of neuromuscular electrostimulation (NMES), effect of neuro electrostimulation (NES), effect of voluntary contractions (VC)
- Keywords
- sympathetic nerve reactivity, neuromuscular electrostimulation
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
effect of neuromuscular electrostimulation (NMES)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)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)Other
Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of voluntary contractions (VC)
| Study group | Role | What they receive |
|---|---|---|
| effect of neuromuscular electrostimulation (NMES) | Experimental | Not described Receives: Device: effect of neuromuscular electrostimulation (NMES) |
| effect of neuro electrostimulation (NES) | Experimental | Not described Receives: Device: effect of neuro electrostimulation (NES) |
| effect of voluntary contractions (VC) | Experimental | Not described Receives: Other: effect of voluntary contractions (VC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: at 0, 5, 10, 15, 20 min of the NES session
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
Measured: at 0, 5, 10, 15, 20 min of the VC session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study start1 Aug 2020
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: Technical issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Joubert, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171351
- Sponsor's protocol ID
- 2014-A00559-38
- Acronym
- ELECTROSYMP2
- Status last verified
- Aug 2020
- First submitted
- 18 Jun 2014
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)
- ClinicalTrials.gov ID
- NCT02171351
- Acronym / sponsor ID
- ELECTROSYMP2 / 2014-A00559-38
- Conditions
- Type 2 Diabetes, Insulin Resistance
- Keywords
- sympathetic nerve reactivity, neuromuscular electrostimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| effect of neuromuscular electrostimulation (NMES) | Experimental | Device: effect of neuromuscular electrostimulation (NMES) |
| effect of neuro electrostimulation (NES) | Experimental | Device: effect of neuro electrostimulation (NES) |
| effect of voluntary contractions (VC) | Experimental | Other: effect of voluntary contractions (VC) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- type 1 diabetes
- treatment with insulin
- seizure
- pace maker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | effect of neuromuscular electrostimulation (NMES) |
| 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) | Device | effect of neuro electrostimulation (NES) |
| 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) | Other | effect of voluntary contractions (VC) |
Primary outcome
Sympathetic nerve reactivity in response to a single session of neuromuscular electrostimulation
Time frame: at 0, 5, 10, 15, 20 min of the NMES session
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
2 secondary outcomes
sympathetic nerve reactivity in response to a single session of neuro electrostimulation
Time frame: at 0, 5, 10, 15, 20 min of the NES session
sympathetic nerve reactivity in response to a single session of voluntary muscular contractions
Time frame: at 0, 5, 10, 15, 20 min of the VC session
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Joubert, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing effect of neuromuscular electrostimulation (NMES), effect of neuro electrostimulation (NES) and effect of voluntary contractions (VC) in people with Type 2 Diabetes and Insulin Resistance, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic nerve reactivity in response to a single session of neuromuscular electrostimulation (time frame: at 0, 5, 10, 15, 20 min of the NMES session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.