Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | High Cholesterol, Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology, Cardiology, Neurology, Epilepsy |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 12/9/2018 |
| Start Date: | March 2016 |
| End Date: | June 2019 |
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.
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.
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
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
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
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