Clinical trial NCT06369571: Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet
Official title: Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Epilepsy
Dyslipidemia
Keywords: Modified Atkins Diet
Ketogenic Diet
Cholesterol
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-04-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diet adherence as assessed by 3 day food records
timeFrame: 12 weeks
measure: Statin Adherence
timeFrame: 12 weeks
measure: LDL Change
timeFrame: 12 weeks
measure: Change in weekly seizure frequency
timeFrame: 12 weeks
measure: Seizure severity questionnaire score
timeFrame: 12 weeks
Secondary outcomes:
measure: Frequency of adverse events
timeFrame: 12 weeks
measure: Blood ketone change
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Tanya J McDonald, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: