Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01465620
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2011-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2011-10-31', 'studyFirstSubmitQcDate': '2011-11-02', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in NTSS6 score at 3 months', 'timeFrame': '3 months', 'description': 'Change from Baseline in NTSS6 score at 3 months (Bastyr EJ, 3rd, Price KL, Bril V. Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clin Ther. 2005 Aug;27(8):1278-94)'}], 'secondaryOutcomes': [{'measure': 'clinical global impression of change', 'timeFrame': '3 months'}, {'measure': 'change from baseline of sensory nerve action potential and sensory and motor nerve velocity', 'timeFrame': '3 months', 'description': 'change from baseline of sensory nerve action potential and sensory and motor nerve velocity at 3 months'}, {'measure': 'change from baseline of thermal and vibration thresholds', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peripheral Nervous System Diseases', 'Diabetic Polyneuropathy', 'Metabolic Syndrome X'], 'conditions': ['Peripheral Nervous System Diseases', 'Diabetic Polyneuropathy', 'Metabolic Syndrome X']}, 'descriptionModule': {'briefSummary': 'Metabolic disorders such as diabetes mellitus, glucose intolerance and possibly metabolic syndrome can induce a peripheral neuropathy. To investigate the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters of patients with metabolic neuropathies.', 'detailedDescription': 'Metabolic disorder such as diabetes mellitus, glucose intolerance and possibly metabolic syndrome can induce a peripheral neuropathy. The objectives of the present study are to investigate:\n\n1. the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters\n2. the best coaching modality of education.\n\nThis will be a prospective single blind study (blinded evaluator). Patients will be randomly assigned in two groups. The first group will have a one-day therapeutic education program followed by a 5-minutes phone call every week for 3 months. The second group will have the same one-day therapeutic education program that will be followed by an unique one-hour phone call. During the one-day therapeutic education program and the phone calls, hygienic rules (ie physical activities) and dietetic regimen advices will be given to patients. Evaluation will be done at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and neurophysiologic neuropathy (clinical signs of neuropathy and at least two low sensory nerve action potential (superficial peroneal and sural nerves))\n* Metabolic disorder: Glucose disorder (diabetes mellitus or glucose intolerance) or metabolic syndrome\n* Clinical signs for less than 2 years\n* No therapeutic modification in the last 3 months\n* Possibility to delay any drug modification during 3 months\n\nExclusion Criteria:\n\n* Non metabolic neuropathy\n* Serious diabetic complication\n* Renal failure (creatinine clearance\\<60ml/min)\n* Sensory neuronopathy\n* Contra-indication to physical activity\n* Type 1 diabetes mellitus\n* No written consent'}, 'identificationModule': {'nctId': 'NCT01465620', 'briefTitle': 'Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study', 'organization': {'class': 'OTHER', 'fullName': 'Henri Mondor University Hospital'}, 'officialTitle': 'Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study', 'orgStudyIdInfo': {'id': 'HM01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coaching', 'description': 'active hygienic-dietetic coaching', 'interventionNames': ['Behavioral: hygienic-dietetic measures']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'reference hygienic-dietetic recommendations', 'interventionNames': ['Behavioral: hygienic-dietetic measures']}], 'interventions': [{'name': 'hygienic-dietetic measures', 'type': 'BEHAVIORAL', 'description': 'Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months', 'armGroupLabels': ['Coaching']}, {'name': 'hygienic-dietetic measures', 'type': 'BEHAVIORAL', 'description': 'Therapeutic education about hygienic-dietetic measures followed by only one phone call', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Alain Créange, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henri Mondor University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henri Mondor University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator, clinical doctor', 'investigatorFullName': 'Sophie Ng Wing Tin', 'investigatorAffiliation': 'Henri Mondor University Hospital'}}}}