Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT02171351
Status:
WITHDRAWN
Last Update Posted:
2022-08-24
First Post:
2014-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Technical issue', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2014-06-18', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'comparison of sympathetic nerve reactivity between the different groups and procedures', 'timeFrame': 'at 0, 5, 10, 15, 20 min of each session', 'description': 'sympathetic nerve reactivity will be compared between type 2 diabetic and healthy subjects and between neuromuscular electrostimulation, neuro electrostimulation and voluntary contractions'}], 'primaryOutcomes': [{'measure': 'Sympathetic nerve reactivity in response to a single session of neuromuscular electrostimulation', 'timeFrame': 'at 0, 5, 10, 15, 20 min of the NMES session', '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'}], 'secondaryOutcomes': [{'measure': 'sympathetic nerve reactivity in response to a single session of neuro electrostimulation', 'timeFrame': 'at 0, 5, 10, 15, 20 min of the NES session', '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'}, {'measure': 'sympathetic nerve reactivity in response to a single session of voluntary muscular contractions', 'timeFrame': 'at 0, 5, 10, 15, 20 min of the VC session', '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sympathetic nerve reactivity', 'neuromuscular electrostimulation'], 'conditions': ['Type 2 Diabetes', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes for at least 12 month\n* treatment by oral hypoglycemic agents and/or GLP1 agonists\n* HbA1c : 6-10%\n* suspected insulin-resistance (at least one criteria below) :\n* waist circumference \\> 80cm (female); \\> 94cm (male)\n* triglycerides \\> 150 mg/dl\n* HDL-cholesterol \\< 50 mg/dl (female); \\< 40 mg/dl (male)\n* low background physical activity (Ricci-Gagnon score \\< 27)\n\nExclusion Criteria:\n\n* type 1 diabetes\n* treatment with insulin\n* seizure\n* pace maker'}, 'identificationModule': {'nctId': 'NCT02171351', 'acronym': 'ELECTROSYMP2', 'briefTitle': 'Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)', 'orgStudyIdInfo': {'id': '2014-A00559-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'effect of neuromuscular electrostimulation (NMES)', 'interventionNames': ['Device: effect of neuromuscular electrostimulation (NMES)']}, {'type': 'EXPERIMENTAL', 'label': 'effect of neuro electrostimulation (NES)', 'interventionNames': ['Device: effect of neuro electrostimulation (NES)']}, {'type': 'EXPERIMENTAL', 'label': 'effect of voluntary contractions (VC)', 'interventionNames': ['Other: effect of voluntary contractions (VC)']}], 'interventions': [{'name': 'effect of neuromuscular electrostimulation (NMES)', 'type': 'DEVICE', 'description': 'Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuromuscular electrostimulation (NMES).', 'armGroupLabels': ['effect of neuromuscular electrostimulation (NMES)']}, {'name': 'effect of neuro electrostimulation (NES)', 'type': 'DEVICE', 'description': 'Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuro electrostimulation (NES)', 'armGroupLabels': ['effect of neuro electrostimulation (NES)']}, {'name': 'effect of voluntary contractions (VC)', 'type': 'OTHER', 'description': 'Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of voluntary contractions (VC)', 'armGroupLabels': ['effect of voluntary contractions (VC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Clinical Research Center Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'Michael Joubert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}