Clinical trial NCT02694094: Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy
Official title: Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypercholesterolemia
Carotid Intimal Medial Thickness 1
Seizure
Epilepsy
Cardiovascular Disease
Cerebrovascular Disease
Heart Disease
Coronary Disease
Keywords: cholesterol
seizure
epilepsy
ketogenic
diet
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: If participants agree to be in this study, the investigators will ask the participants to do the following things:

At Initial enrollment for both longterm ketogenic diet and new modified Atkins diet participants

* Review of calendars (showing seizures) and 3-day food record
* Check height and weight, blood pressure, skin-fold thickness and waist circumference
* 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
* 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

At follow-up clinic visits (month 3 and month 6) for new modified Atkins diet participants

* Review of calendars and food records
* 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
* Check height and weight, blood pressure, skin-fold thickness and waist circumference

At follow-up clinic visits (month 12 and month 24) for new modified Atkins diet participants

* Review of calendars and food records
* 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
* Check height and weight, blood pressure, skin-fold thickness and waist circumference
* 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

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Body mass index (BMI) \> 18.5
* Stable antiepileptic drug regimen for \> 1 month.

Exclusion Criteria:

* \< 18 years of age
* Body mass index (BMI) \< 18.5
* Changes in antiepileptic drug regimen \< 1 month prior to participation
* Previous cardiovascular event or treatment ((including myocardial infarction, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI))
* Acute pancreatitis
* Unwilling to restrict carbohydrates
* Kidney disease
* Contraindicated metabolic or mitochondrial disorder

Primary outcomes:
measure: Change in carotid artery intima-media thickness (mm) measured by carotid artery ultrasound
timeFrame: Baseline and 12 months post diet implementation
measure: Change in LDL fractions (nmol/L)
timeFrame: Baseline and 12 months post diet implementation
Secondary outcomes:
measure: Change in LDL fractions (nmol/L)
timeFrame: Baseline and 3 months post diet implementation
measure: Change in apolipoproteins (mg/dL)
timeFrame: Baseline and 3 months post diet implementation
measure: Change in apolipoproteins (mg/dL)
timeFrame: Baseline and 6 months post diet implementation
measure: Change in apolipoproteins (mg/dL)
timeFrame: Baseline and 12 months post diet implementation
measure: Change in apolipoproteins (mg/dL)
timeFrame: Baseline and 24 months post diet implementation
measure: Change in LDL fractions (nmol/L)
timeFrame: Baseline and 6 months post diet implementation
measure: Change in LDL fractions (nmol/L)
timeFrame: Baseline and 24 months post diet implementation
measure: Change in carotid artery intima-media thickness (mm) measured by carotid artery
timeFrame: Baseline and 24 months post diet implementation
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mackenzie C Cervenka, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.