Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 5:39 PM
Study NCT ID:
NCT02694094
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-10
First Post:
2016-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'C563733', 'term': 'Carotid Intimal Medial Thickness 1'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2016-02-16', 'studyFirstSubmitQcDate': '2016-02-23', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in carotid artery intima-media thickness (mm) measured by carotid artery ultrasound', 'timeFrame': 'Baseline and 12 months post diet implementation', 'description': 'Carotid artery ultrasound will be used to measure the change in average intima-media thickness over time with comparisons between baseline and 12 months of diet therapy.'}, {'measure': 'Change in LDL fractions (nmol/L)', 'timeFrame': 'Baseline and 12 months post diet implementation', 'description': 'The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 12 months of diet therapy.'}], 'secondaryOutcomes': [{'measure': 'Change in LDL fractions (nmol/L)', 'timeFrame': 'Baseline and 3 months post diet implementation', 'description': 'The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 3 months of diet therapy.'}, {'measure': 'Change in apolipoproteins (mg/dL)', 'timeFrame': 'Baseline and 3 months post diet implementation', 'description': 'The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 3 months of diet therapy.'}, {'measure': 'Change in apolipoproteins (mg/dL)', 'timeFrame': 'Baseline and 6 months post diet implementation', 'description': 'The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 6 months of diet therapy.'}, {'measure': 'Change in apolipoproteins (mg/dL)', 'timeFrame': 'Baseline and 12 months post diet implementation', 'description': 'The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 12 months of diet therapy.'}, {'measure': 'Change in apolipoproteins (mg/dL)', 'timeFrame': 'Baseline and 24 months post diet implementation', 'description': 'The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 24 months of diet therapy.'}, {'measure': 'Change in LDL fractions (nmol/L)', 'timeFrame': 'Baseline and 6 months post diet implementation', 'description': 'The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 6 months of diet therapy.'}, {'measure': 'Change in LDL fractions (nmol/L)', 'timeFrame': 'Baseline and 24 months post diet implementation', 'description': 'The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 24 months of diet therapy.'}, {'measure': 'Change in carotid artery intima-media thickness (mm) measured by carotid artery', 'timeFrame': 'Baseline and 24 months post diet implementation', 'description': 'Carotid artery ultrasound will be used to measure the change in average intima-media thickness over time with comparisons between baseline and 24 months of diet therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cholesterol', 'seizure', 'epilepsy', 'ketogenic', 'diet'], 'conditions': ['Hypercholesterolemia', 'Carotid Intimal Medial Thickness 1', 'Seizure', 'Epilepsy', 'Cardiovascular Disease', 'Cerebrovascular Disease', 'Heart Disease', 'Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '33487129', 'type': 'DERIVED', 'citation': 'McDonald TJW, Diaz-Arias L, Vizthum D, Henry-Barron BJ, Schlechter H, Kossoff EH, Cervenka MC. Six-month effects of modified Atkins diet implementation on indices of cardiovascular disease risk in adults with epilepsy. Nutr Neurosci. 2022 Jul;25(7):1548-1557. doi: 10.1080/1028415X.2021.1875301. Epub 2021 Jan 23.'}], 'seeAlsoLinks': [{'url': 'https://www.hopkinsmedicine.org/neurology_neurosurgery/centers_clinics/epilepsy/diet-therapy.html', 'label': 'Ketogenic Diet Therapy for Epilepsy'}]}, 'descriptionModule': {'briefSummary': 'This research is being done to evaluate the short term and long term effects of ketogenic diets on measures of cardiovascular health. Such measures include cholesterol levels, blood pressure, weight, and thickening of the blood vessel wall over time. Adults aged 18 or older who are already on a ketogenic diet for at least 12 months or who are interested in beginning on the modified Atkins diet may join.', 'detailedDescription': 'If participants agree to be in this study, the investigators will ask the participants to do the following things:\n\nAt Initial enrollment for both longterm ketogenic diet and new modified Atkins diet participants\n\n* Review of calendars (showing seizures) and 3-day food record\n* Check height and weight, blood pressure, skin-fold thickness and waist circumference\n* Standard modified Atkins diet clinic labs will be drawn as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1\n* Participant will receive a high-resolution ultrasound of the carotid arteries in the neck performed either the day of enrollment or within 1 month of enrollment\n\nAt follow-up clinic visits (month 3 and month 6) for new modified Atkins diet participants\n\n* Review of calendars and food records\n* Labs repeated - standard modified Atkins diet clinic labs as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1\n* Check height and weight, blood pressure, skin-fold thickness and waist circumference\n\nAt follow-up clinic visits (month 12 and month 24) for new modified Atkins diet participants\n\n* Review of calendars and food records\n* Labs repeated - standard modified Atkins diet clinic labs as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1\n* Check height and weight, blood pressure, skin-fold thickness and waist circumference\n* Participants will receive a high-resolution ultrasound of the carotid arteries in the neck performed either the day of follow-up or within 1 month of follow-up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will be drawn from among participants in the Johns Hopkins Adult Epilepsy Diet Center and Johns Hopkins Epilepsy Center who are age 18 or older, with body mass index (BMI) \\> 18.5, and on a stable antiepileptic drug regimen for \\> 1 month.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Body mass index (BMI) \\> 18.5\n* Stable antiepileptic drug regimen for \\> 1 month.\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* Body mass index (BMI) \\< 18.5\n* Changes in antiepileptic drug regimen \\< 1 month prior to participation\n* Previous cardiovascular event or treatment ((including myocardial infarction, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI))\n* Acute pancreatitis\n* Unwilling to restrict carbohydrates\n* Kidney disease\n* Contraindicated metabolic or mitochondrial disorder'}, 'identificationModule': {'nctId': 'NCT02694094', 'briefTitle': 'Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy', 'orgStudyIdInfo': {'id': 'IRB00070557'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults on Chronic ketogenic diets', 'description': 'Adults who have been on Modified Atkins or ketogenic diets for over 1 year', 'interventionNames': ['Dietary Supplement: Modified Atkins or Ketogenic Diet']}, {'label': 'Adults naive to ketogenic diets', 'description': 'Adults who have never been on Modified Atkins or ketogenic diets'}], 'interventions': [{'name': 'Modified Atkins or Ketogenic Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Biochemical and vascular parameters will be compared from adults who have been on ketogenic diet therapy for \\> 12 months to adults naive to ketogenic diet therapy. In addition, adults naive to diet therapy who subsequently begin diet therapy will have these same parameters followed over time.', 'armGroupLabels': ['Adults on Chronic ketogenic diets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Mackenzie C Cervenka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}