Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369571
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-04-12
Brief Title:
Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
AWE with dyslipidemia on long-term MAD will be randomized 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None