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Enrolling By Invitation
NCT06369571
Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet
Conditions: Epilepsy, Dyslipidemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 22
Sponsor: Johns Hopkins University
Location: Johns Hopkins Hospital Baltimore Maryland
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.
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
Source: ClinicalTrials.gov (NCT06369571). StuddyBuddy aggregates publicly available trial information.