A Study of Genetic Influence on LDL Hyper-responsiveness... | NCT07137286

Studies
A Study of Genetic Influence on LDL Hyper-responsiveness in Patients Following a Ketogenic Diet

NCT07137286

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Nov 20, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

LDL Hyper-responsiveness

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2025Actual

Primary Completion Date

Aug 2027Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Aug 15, 2025

First Submission Date that Met QC Criteria

Aug 15, 2025

First Posted Date

Aug 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2025

Last Update Posted Date

Nov 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to identify whether individuals following a ketogenic diet who experience extreme LDL-C elevation, termed "hyper-responders", have identifiable genetic variations in genes involved in cholesterol absorption.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients to have a genetic mutation	Genetic Mutation will be defined as a mutation in ABCG5, ABCG8, APOB, APOE, CETP, CYP27A1, LDLR, LDLRAP1, LIPA, LPL, LRP6, and PCSK9 genes	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
LDL-C >170 mg/dL in response to starting a ketogenic diet

Exclusion Criteria:

Patients who do not consent to blood draw for genetic testing
Those with LDL-C <170 mg/dL on a ketogenic diet

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Male and female participants 18 years and older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Saad Omar	Contact	507-538-5162		omar.saad@mayo.edu

Overall Officials

Name	Affiliation	Role
Stephen Kopecky, M.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic	Recruiting	Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided