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Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

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ClinicalTrials.gov Identifier: NCT02694094
Recruitment Status : Enrolling by invitation
First Posted : February 29, 2016
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment
Hypercholesterolemia Carotid Intimal Medial Thickness 1 Seizure Epilepsy Cardiovascular Disease Cerebrovascular Disease Heart Disease Coronary Disease Dietary Supplement: Modified Atkins or Ketogenic Diet

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

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy
Study Start Date : March 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
Adults on Chronic ketogenic diets
Adults who have been on Modified Atkins or ketogenic diets for over 1 year
Dietary Supplement: Modified Atkins or Ketogenic Diet
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.

Adults naive to ketogenic diets
Adults who have never been on Modified Atkins or ketogenic diets



Primary Outcome Measures :
  1. Changes in LDL fractions (nmol/L) [ Time Frame: Change from baseline and 3-months post diet implementation. ]
    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.

  2. Changes in carotid artery intima-media thickness (mm) measured by carotid artery ultrasound [ Time Frame: Change from baseline and 12 months post diet implementation. ]
    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.

  3. Changes in apolipoproteins (mg/dL) [ Time Frame: Change from baseline and 3-months post diet implementation. ]
    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.

  4. Changes in apolipoproteins (mg/dL) [ Time Frame: Change from baseline and 6-months post diet implementation. ]
    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.

  5. Changes in apolipoproteins (mg/dL) [ Time Frame: Change from baseline and 12-months post diet implementation. ]
    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.

  6. Changes in apolipoproteins (mg/dL) [ Time Frame: Change from baseline and 24-months post diet implementation. ]
    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.

  7. Changes in LDL fractions (nmol/L) [ Time Frame: Change from baseline and 6-months post diet implementation. ]
  8. Changes in LDL fractions (nmol/L) [ Time Frame: Change from baseline and 12-months post diet implementation. ]
  9. Changes in LDL fractions (nmol/L) [ Time Frame: Change from baseline and 24-months post diet implementation. ]
  10. Changes in carotid artery intima-media thickness (mm) measured by carotid artery [ Time Frame: Change from baseline and 24 months post diet implementation. ]

Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694094


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Mackenzie C Cervenka, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02694094     History of Changes
Other Study ID Numbers: IRB00070557
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
cholesterol
seizure
epilepsy
ketogenic
diet

Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Epilepsy
Seizures
Hypercholesterolemia
Coronary Disease
Coronary Artery Disease
Cerebrovascular Disorders
Atherosclerosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases