Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT02565966
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2015-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-16', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuroinflammation markers in blood', 'timeFrame': 'At time of surgery (approximately 3-4 weeks after randomization)', 'description': 'As measured by level of cytokines IL-6, TNF alpha, and C-reactive protein in blood samples'}, {'measure': 'Metabolism', 'timeFrame': 'At time of surgery (approximately 3-4 weeks after randomization)', 'description': 'As measured by level of fasting lipid profile, acylcarnitine profile, and beta-hydroxybutyrate in blood'}, {'measure': 'Neuroinflammation markers in brain tissue', 'timeFrame': 'At time of surgery (approximately 3-4 weeks after randomization)', 'description': 'As measured by level of cytokines, IL6, TNF alpha, and microglial activation and proliferation in brain tissue obtained during durgery'}, {'measure': 'Levels of leptin in brain tissue', 'timeFrame': 'At time of surgery (approximately 3-4 weeks after randomization)'}, {'measure': 'Levels of adenosine in brain tissue', 'timeFrame': 'At time of surgery (approximately 3-4 weeks after randomization)'}, {'measure': 'Levels of adenosine kinase in brain tissue', 'timeFrame': 'At time of surgery (approximately 3-4 weeks after randomization)'}, {'measure': 'Levels of adenosite-1 (A1) receptors in brain tissue', 'timeFrame': 'At time of surgery (approximately 3-4 weeks after randomization)'}, {'measure': 'Levels of enzymes that synthesize glutamate and GABA', 'timeFrame': 'At time of surgery (approximately 3-4 weeks after randomization)', 'description': 'As measured in brain tissue obtained during surgery'}]}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '36775798', 'type': 'DERIVED', 'citation': 'Leitner DF, Siu Y, Korman A, Lin Z, Kanshin E, Friedman D, Devore S, Ueberheide B, Tsirigos A, Jones DR, Wisniewski T, Devinsky O. Metabolomic, proteomic, and transcriptomic changes in adults with epilepsy on modified Atkins diet. Epilepsia. 2023 Apr;64(4):1046-1060. doi: 10.1111/epi.17540. Epub 2023 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to better define the potential molecular and anti-inflammatory changes induced by the modified Atkins diet in the brains of patients with treatment resistant epilepsy. The investigators plan to enroll 30 subjects overall in this study to compare serologic and brain tissue specimens. At NYU, investigators plan to enroll 20 subjects; an estimated ten (10) subjects will consume a modified Atkins diet for 3-4 weeks prior to surgery and an estimated ten (10) subjects will consume a non-modified, higher carbohydrate diet. Investigators at Saint Barnabas Medical Center plan to enroll 10 subjects in this study to compare serologic and brain tissue specimens. Approximately five (5) subjects will consume a modified Atkins diet for 3-4 weeks prior to surgery and five (5) subjects will consume a non-modified, higher carbohydrate diet. Blood and brain tissue specimens will be obtained at the time of surgery and will be compared. The goal of this study is to identify whether or not there are changes in neuroinflammation or neuroexcitability in the human brain induced by the modified Atkins diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients scheduled for epilepsy surgery at New York Langone Medical Center or St Barnabas Medical Center will be eligible for enrollment.\n\n* Patient is at least 18 years of age\n* Patient is willing to participate by complying with the modified Atkins diet 3 - 4 weeks prior to surgery and maintain a thorough food diary (Intervention study group) or to continue their usual diet and maintain a thorough food diary (Nonintervention study group)\n* Patient/ his/her parent, caregiver, or health care proxy is willing and able to provide consent or assent\n\nExclusion Criteria:\n\n* Patients under the age of 18 will be excluded\n* Patients in whom a two-stage surgery is planned without any resection of brain tissue during the initial craniotomy\n* Patients unwilling to comply with modified Atkins diet 3 -4 weeks prior to surgery or unwilling to maintain a thorough food diary will be excluded.\n* Patients who are currently on an Atkins or Low Glycemic Index Diet will not be eligible for inclusion in the nonintervention group.'}, 'identificationModule': {'nctId': 'NCT02565966', 'briefTitle': 'Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues', 'orgStudyIdInfo': {'id': '14-01069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Atkins Diet (MAD)', 'interventionNames': ['Other: Modified Atkins Diet (MAD)']}, {'type': 'NO_INTERVENTION', 'label': 'Normal Diet', 'description': 'Those patients in the normal diet (no intervention) group will also meet with the epilepsy center nutritionist to review the food diary and completion of this document, similar to those in the intervention (MAD) group. No dietary restrictions will be made in this group.'}], 'interventions': [{'name': 'Modified Atkins Diet (MAD)', 'type': 'OTHER', 'description': 'For those in the MAD intervention group, the dietitian trains the patient and family in the preparation and management of this specialized therapy including sick-day guidelines, meal planning, carbohydrate counting and trouble-shooting. Written and verbal education including, but not limited to: recipes, education materials, sample meal plans and carbohydrate counters are provided to the patient during the initial education session. The caregiver/patient is trained in the outpatient setting and the diet is implemented at home with as much email/phone support from the dietician and ketogenic team as the patient needs to successfully maintain the diet. Medications are all changed over to the lowest carbohydrate forms to eliminate excess carbohydrate intake and all patients are started on vitamin supplements to maintain adequate nutrition.', 'armGroupLabels': ['Modified Atkins Diet (MAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07039', 'city': 'Livingston', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Institute of Neurology and Neurosurgery at Saint Barnabas', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Epilepsy Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Orrin Devinsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Epilepsy Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Barnabas Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}