Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02694094
Study type	Observational
Source	Johns Hopkins University
Contact
Status	Enrolling by invitation
Phase
Start date	March 2016
Completion date	December 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.