Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet

Epilepsy Clinical Trial

Official title:

Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369571
• Other study ID #: IRB00439268
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2024
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: Tanya J McDonald, MD, PhD
• Phone: 4105022227
• Email: twill145[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ketogenic diet therapies (KDTs) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. However, KDT use can lead to increased cholesterol levels in some adults with epilepsy (AWE). Treatments that can reverse elevations in cholesterol observed with long-term KDT use without compromising diet adherence and seizure control are needed. The proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. Study findings will help guide doctors utilizing KDTs in adults with epilepsy on how to approach managing elevations in cholesterol.

Description:

The scientific premise of this proposal is that established or long-term (≥ 12 months) Modified Atkins diet (MAD) use in AWE influences atherosclerotic cardiovascular disease (ASCVD) risk and can be modified to reduce dyslipidemia when observed. Hence, the overarching goals of this proposal are to explore the safety and feasibility of dyslipidemia management strategies to reduce ASCVD risk in AWE on MAD without increasing seizure risk. This study will collect data before and after randomly assigned interventions to reduce LDL in AWE on long-term MAD recruited from patients receiving clinical care in the Johns Hopkins Adult Epilepsy Diet Center. AWE with dyslipidemia on long-term MAD will be randomized 1:1 to either MAD modification (10% reduction of dietary energy from saturated fat, replaced with poly-unsaturated fat ) or moderate-intensity statin use (atorvastatin 10mg) for 12 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: December 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Modified Atkins Diet use = 12 months

2. Dyslipidemia based on American College of Cardiology/American Heart Association guidelines (i.e., LDL =190 mg/dL, 10-year ASCVD risk =5% with risk enhancers, etc.)

3. 18 years of age or older

4. Body mass index (BMI) > 18.5

5. Stable anti-seizure medication regimen for > 1 month.

Exclusion Criteria:

1. < 18 years of age

2. Body mass index (BMI) < 18.5

3. Changes in anti-seizure medication regimen < 1 month prior to participation

4. Known ASCVD (history of acute coronary syndrome, myocardial infarction, angina, stroke, transient ischemic attack, or peripheral artery disease)

5. Current statin medication use

6. Prior serious adverse response to atorvastatin or other statin medications

7. Uncorrected carnitine deficiency

8. Pregnancy

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Epilepsy

Intervention

Drug:
• Atorvastatin 10mg
Atorvastatin 10mg daily by mouth

Other:
• Modification of dietary fat composition
Replace 10% of saturated fat intake with polyunsaturated fat

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	American Heart Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet adherence as assessed by 3 day food records	Diet adherence will be based on the ability to achieve 10% reduction in dietary energy from saturated fat assessed from 3-day food records, the gold standard for diet intake assessments.	12 weeks
Primary	Statin Adherence	Statin adherence will be determined based on pills returned at study completion, with participants labeled adherent if 80% or more of pills were consumed.	12 weeks
Primary	LDL Change	12-week % LDL change from baseline within arms and between arms	12 weeks
Primary	Change in weekly seizure frequency	12-week difference in weekly seizure frequency from baseline	12 weeks
Primary	Seizure severity questionnaire score	12-week difference in seizure severity questionnaire (SSQ) score (score 1-7, with higher score indicating more severe seizures)	12 weeks
Secondary	Frequency of adverse events	Frequency of adverse events	12 weeks
Secondary	Blood ketone change	12-week difference in serum beta-hydroxybutyrate level from baseline	12 weeks