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:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: