Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-04 @ 2:55 PM
Study NCT ID:
NCT01503892
Status:
UNKNOWN
Last Update Posted:
2012-07-17
First Post:
2011-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D000071075', 'term': 'Small Fiber Neuropathy'}], 'ancestors': [{'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': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C575384', 'term': 'metanx'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-16', 'studyFirstSubmitDate': '2011-12-29', 'studyFirstSubmitQcDate': '2011-12-31', 'lastUpdatePostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increased intraepidermal nerve fiber density', 'timeFrame': '1 year', 'description': 'If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density'}], 'secondaryOutcomes': [{'measure': 'Subjective improvement', 'timeFrame': '1 year', 'description': 'Improvement in the subjective score versus the placebo group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Small Fiber Neuropathy', 'Metanx Effect on Small Fiber Neuropathy', 'Metanx Effect on Diabetic Peripheral Neuropathy'], 'conditions': ['Diabetes', 'Peripheral Neuropathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.goldfarbfoundation.org/', 'label': 'William L. Goldfarb Educational Foundation for Research and Teaching of the Lower Extremity'}, {'url': 'http://www.mystlukesonline.org', 'label': "St. Luke's Hospital and Health Network"}]}, 'descriptionModule': {'briefSummary': 'This study focuses on the use of Metanx® as the sole treatment for improving and reversing nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two equal study groups enrolled in this randomized double blinded study. The minimum sample size of enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. The maximum number of participants will be set at 100 (50 per group). Patients who are pre-diabetic or patients who have been diagnosed with diabetes type II for less than five years are included in this study. The control group will receive placebo pill twice daily versus the treatment group which will receive one Metanx® tablet twice daily. Each group will have intraepidermal nerve fiber densities obtained by skin biopsies taken at the beginning of the study before any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of twelve months to re-biopsy. In addition each group will answer three sets of questionnaires relating to their peripheral neuropathy at initial, three months, twelve month visitations. If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density and an improvement in the subjective score versus the placebo group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetics\n* Pre-diabetics\n* Symptoms of peripheral neuropathy\n\nExclusion Criteria:\n\n* Pregnancy\n* Under age 18\n* HIV (+)'}, 'identificationModule': {'nctId': 'NCT01503892', 'acronym': 'SLHN2011-18', 'briefTitle': 'Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's Hospital and Health Network, Pennsylvania"}, 'officialTitle': 'Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics', 'orgStudyIdInfo': {'id': 'StLukeHHN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The control group will receive placebo pill twice daily for twelve months.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metanx', 'description': 'Metanx group will receive one pill twice daily for twelve months.', 'interventionNames': ['Dietary Supplement: Metanx']}], 'interventions': [{'name': 'Metanx', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Metanx- one tablet twice daily for twelve months', 'armGroupLabels': ['Metanx']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo- one tablet twice daily for twelve months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edwin S. Hart III, DPM', 'role': 'CONTACT', 'email': 'ehart@footmed.com', 'phone': '610-868-4300'}], 'facility': "St. Luke's Hospital and Health Network", 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}], 'centralContacts': [{'name': 'Edwin S. Hart III, DPM', 'role': 'CONTACT', 'email': 'ehart@footmed.com', 'phone': '610-868-4300'}], 'overallOfficials': [{'name': 'Edwin S. Hart III, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's Hospital and Health Network"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's Hospital and Health Network, Pennsylvania", 'class': 'OTHER'}, 'collaborators': [{'name': 'Goldfarb Foundation', 'class': 'UNKNOWN'}, {'name': 'Pamlab, L.L.C.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Edwin S. Hart III', 'investigatorAffiliation': "St. Luke's Hospital and Health Network, Pennsylvania"}}}}