Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-04-15 @ 11:23 PM
Study NCT ID:
NCT02293135
Status:
UNKNOWN
Last Update Posted:
2015-05-22
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Stendo Pulsating Suit on Microcirculation and Endothelial Function in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2014-11-13', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral microcirculation measured using Laser Doppler flowmetry', 'timeFrame': '30 minutes after the end of the Stendo session', 'description': 'Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session'}], 'secondaryOutcomes': [{'measure': 'Arterial stiffness', 'timeFrame': '10 minutes after the end of Stendo session', 'description': 'Change of arterial stiffness using an applanation tonometry device after one Stendo pulsating suit session; Augmentation Index and sub-endocardial viability ratio will also be assessed'}, {'measure': 'Heart Rate Variability (HRV)', 'timeFrame': '15 minutes after the end of Stendo session', 'description': 'HRV is calculated from continuous noninvasive arterial pressure records and continuous high resolution 3-lead, 6channel ECG records'}, {'measure': 'Endothelium-dependant microvascular flow after local acetylcholine iontophoresis', 'timeFrame': '35 minutes after the end of Stendo session', 'description': '3 minutes Area Under Curve (AUC) of the peripheral microcirculation using Laser Doppler flowmetry'}, {'measure': 'Reactive Hyperemia Index (RHI)', 'timeFrame': '45 minutes after the end of Stendo session', 'description': 'RHI is the post-to-pre occlusion Peripheral Arterial Tone (PAT) signal ratio in the occluded arm, relative to the same ratio in the control arm'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 diabetes ; endothelium stimulation'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '36550568', 'type': 'DERIVED', 'citation': 'Valensi P, Barber-Chamoux N, Rezki A, Lambert C, Pereira B, Duale C, Delmas D, Duclos M. Effects of single and multiple sessions of lower body diastole-synchronized compressions using a pulsating pneumatic suit on endothelium function and metabolic parameters in patients with type 2 diabetes: two controlled cross-over studies. Cardiovasc Diabetol. 2022 Dec 22;21(1):286. doi: 10.1186/s12933-022-01710-6.'}]}, 'descriptionModule': {'briefSummary': 'The action of one Stendo pulsating suit session will be evaluated on 16 type 2 diabetic patients referred on the diabetic consultations. The effects of one Stendo pulsating suit session system will be assessed on the peripheral cutaneous microcirculation and on endothelial functions', 'detailedDescription': 'The role of the endothelium in micro-vascular system is mediated by synthesis and release of numerous substances that act on the smooth muscle fibers. The release of these products is modulated, in turn, by various circulating molecules, by autonomic nervous system and by local mechanical factors such as shear stress.\n\nThe type 2 diabetes leads to early vascular redesign with the onset of endothelial dysfunction and the worsening of the arterial stiffness.\n\nThese anomalies, well correlated with the cardiovascular risks, are currently investigated in the department of Endocrinology, Diabetes, and Nutrition at the Jean Verdier Hospital. The analysis methods allow identifying early modifications in response to various drugs, nutritional or physical stimuli.\n\nThe aim of this study is therefore to evidence a peripheral microcirculation and endothelial function improvement in type 2 diabetic patient in comparison to a cross-over control session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetic patient\n* Diagnosis of diabetes \\> 1 year\n* HBA1c between 6 and 8,5\n* Treated with oral anti-diabetic, insulin and/or incretins which can be stayed unchanged during the 2-week study\n\nExclusion Criteria:\n\n* Type 1 diabetic Patient\n* Antecedent of cardiomyopathy, cardiac ischemia or valvulopathy\n* Severe kidney failure\n* Non controlled hypertension (\\> 160/100mm Hg)\n* Cardiac arrhythmia\n* Severe respiratory failure\n* Patient with an advanced obstructive arterial disease\n* Patient with a recent and progressive deep venous thrombosis'}, 'identificationModule': {'nctId': 'NCT02293135', 'acronym': 'Diabete_1', 'briefTitle': 'Evaluation of Stendo Pulsating Suit on Microcirculation and Endothelial Function in Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stendo'}, 'officialTitle': 'Evaluation of the Action of the Stendo Pulsating Suit on Peripheral Microcirculation and on Endothelial Function in Diabetic Patients Without Complication', 'orgStudyIdInfo': {'id': '2014-A00961-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Verum Stendo session on V1 and Phantom Stendo session on V2', 'interventionNames': ['Device: Verum Stendo session on V1 and Phantom Stendo session on V2']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Phantom Stendo session on V1 and Verum Stendo session on V2', 'interventionNames': ['Device: Phantom Stendo session on V1 and Verum Stendo session on V2']}], 'interventions': [{'name': 'Verum Stendo session on V1 and Phantom Stendo session on V2', 'type': 'DEVICE', 'description': 'On the firt V1 visit, the patient will receive the verum Stendo session ; then on V2 visit ((V1 + 13 days +/- 2), the patient will receive the verum Stendo session On the firt visit, V1 the patient will have a phantom Stendo session (no pressure will be applied)', 'armGroupLabels': ['Group 1']}, {'name': 'Phantom Stendo session on V1 and Verum Stendo session on V2', 'type': 'DEVICE', 'description': 'On the firt V1 visit, the patient will have a phantom Stendo session (no pressure will be applied) ; then on V2 visit ((V1 + 13 dayx +/- 2), the patient will receive the verum Stendo session', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93143', 'city': 'Bondy', 'status': 'RECRUITING', 'country': 'France', 'facility': "Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie Nutrition", 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}], 'centralContacts': [{'name': 'Paul VALENSI, Professor', 'role': 'CONTACT', 'email': 'paul.valensi@jvr.aphp.fr', 'phone': '+33 1 48 02 65 97'}, {'name': 'Badreddine MERIOUD, MD', 'role': 'CONTACT', 'email': 'badreddine.merioud@jvr.ap-hop-paris.fr', 'phone': '+ 33 148 02 65 99'}], 'overallOfficials': [{'name': 'Paul VALENSI, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Jean Verdier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stendo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}