Evaluation of HDL Subfraction Changes and HDL-Associated... | NCT05958420

Studies
Evaluation of HDL Subfraction Changes and HDL-Associated Enzymes in Liver Failure Patients and Healthy Donors

NCT05958420

Sponsor

Akdeniz University

Status

Completed

Last Update Posted

Jul 24, 2023Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Liver Failure

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jan 15, 2022Actual

Completion Date

Jan 15, 2022Actual

First Submitted Date

Jul 6, 2023

First Submission Date that Met QC Criteria

Jul 13, 2023

First Posted Date

Jul 24, 2023Actual

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

Jul 13, 2023

Last Update Posted Date

Jul 24, 2023Actual

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

This study aimed to determine high-density lipoprotein (HDL) subfraction profile and HDL-associated enzyme changes in liver failure patients and healthy donors.

Detailed Description

Objectives: This study aimed to determine high-density lipoprotein (HDL) subfraction profile and HDL-associated enzyme changes in liver failure patients and healthy donors.

Materials and Methods: Twenty liver failure patients and twenty healthy donors are selected. Blood samples obtained from all patients prior to transplant will analyzed. HDL subfraction analysis will done by continuous disc polyacrylamide gel electrophoresis. Plasma levels of apolipoprotein A-1 (ApoA-I), cholesteryl ester transfer protein (CETP), and lecithin-cholesterol acyltransferase (LCAT) will determined by enzyme-linked immunosorbent assay.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Patients with liver failure
Group 2		Healthy donors

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HDL Subfractions	Evaluation of HDL Subfractions in groups	Blood will collected from all patients before surgery

Secondary Outcomes

Measure	Description	Time Frame
HDL-associated enzymes	ApoA1, CETP and LCAT levels in groups	Blood will collected from all patients before surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Liver failure patients

Exclusion Criteria:

patients not giving consent
Participants who had oncological and hematological diseases, coronary failure, kidney failure, malnutrition, diabetes, traumatic brain injury, or cadaveric LT and who were using psychoactive medicines or having a respiratory system or CNS diseases were excluded from the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All consecutive patients who underwent living donor LT procedure between 2018 and 2019.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
İlker O Aycan	Akdeniz University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AkdenizU		Antalya			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D017093	Liver Failure

Ancestor Terms

ID	Term
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided