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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

Tracking Information
First Submitted Date February 16, 2016
First Posted Date February 29, 2016
Last Update Posted Date December 7, 2018
Study Start Date March 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Changes in LDL fractions (nmol/L) [ Time Frame: Change from baseline and 6-months post diet implementation. ]
  • Changes in LDL fractions (nmol/L) [ Time Frame: Change from baseline and 12-months post diet implementation. ]
  • Changes in LDL fractions (nmol/L) [ Time Frame: Change from baseline and 24-months post diet implementation. ]
  • Changes in carotid artery intima-media thickness (mm) measured by carotid artery [ Time Frame: Change from baseline and 24 months post diet implementation. ]
Original Primary Outcome Measures
 (submitted: February 23, 2016)
  • Changes in extended lipid profile [ Time Frame: baseline, 3, 6,12, and 24 months ]
    The change in levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 3,6,12, and 24 months of diet therapy.
  • Changes in carotid artery intima-media thickness measured by carotid artery ultrasound [ Time Frame: baseline, 12 and 24 months ]
    Carotid artery ultrasound will be used to measure the change in average intima-media thickness over time with comparisons between baseline and 12 and 24 months of diet therapy.
Change History Complete list of historical versions of study NCT02694094 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy
Official Title Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy
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
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples
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.
Condition
  • Hypercholesterolemia
  • Carotid Intimal Medial Thickness 1
  • Seizure
  • Epilepsy
  • Cardiovascular Disease
  • Cerebrovascular Disease
  • Heart Disease
  • Coronary Disease
Intervention 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.
Study Groups/Cohorts
  • Adults on Chronic ketogenic diets
    Adults who have been on Modified Atkins or ketogenic diets for over 1 year
    Intervention: Dietary Supplement: Modified Atkins or Ketogenic Diet
  • Adults naive to ketogenic diets
    Adults who have never been on Modified Atkins or ketogenic diets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: February 23, 2016)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02694094
Other Study ID Numbers IRB00070557
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators Not Provided
Investigators
Principal Investigator: Mackenzie C Cervenka, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date December 2018