Serum Level of Lipopolysaccharide-binding Protein (LBP) and Atherosclerosis in Hemodialysis Patients

May 29, 2022 updated by: Tungs' Taichung Metroharbour Hospital

Association of Lipopolysaccharide-binding Protein (LBP) and Atherosclerotic Vascular Disease in Taiwanese Hemodialysis Patients

Background In hemodialysis (HD) patients, impaired gut barrier and alteration in microbiota in the gut is thought to increase the risk of bacterial translocation and chronic inflammation. Lipopolysaccharide-binding protein (LBP) is an acute-phase reactant that mediates immune responses triggered by microbial products. Our aim is to investigate the relationship between circulating levels of LBP, inflammatory markers and incident atherosclerotic vascular events in HD patients and follow-up this defined cohort for 3 years.

Methods A total of 300 HD patients will be recruited. The LBP and inflammatory markers will be determined using immuoassay methods annually. A bioimpedance spectroscopy device will used for body fat composition measurement and measurements will be done annually. Arterial stiffness is evaluated by measuring PWV in the heart-femoral segment using an automatic waveform analyzer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Study Design and Population

Patient Population

To be included in the study, patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months. Patients are excluded if they had an acute infection or malignancy. A total of 360 long-term HD patients are randomly invited and agreed to participate in the study. The medical record is thoroughly reviewed for each subject by a collaborating physician in the study. Information such as underlying kidney disease, cardiovascular disease history, and other comorbid illnesses will be abstracted.

Study Parameters

Predialysis blood samples are obtained on a mid-week day. Within 30 min after sampling, the remaining blood is centrifuged at 3,000 g for 10 min, immediately aliquoted and frozen at -70°C until further analysis. Total serum cholesterol is measured through the reaction of cholesterol esterase/cholesterol oxidase/peroxidase, using Hitachi 747 (Hitachi, Bohemia, NY, USA). HDL cholesterol is quantified after precipitation with polyethylene glycol at room temperature. Serum glucose concentrations are measured by the glucose oxidase method. Low-density lipoprotein cholesterol is calculated using the Friedewald formula. Total serum triglycerides are measured through the reaction of glycerol/phosphate/oxidase and peroxidase. The serum levels of high-sensitivity C-reactive protein (hsCRP) are measured using a Behring Nephelometer II (Dade Behring, Tokyo, Japan). Plasma levels of Interleukin-6 (IL-6) and soluble CD14(sCD14) are measured by a commercially available enzyme linked immunosorbent assay (ELISA) (Quantikine HS Immunoassay kit, R&D System, Minneapolis, MN). Concentrations Interleukin-6(IL-10), and Tumor necrosis factor-alpha(TNF-α) are simultaneously determined by the Multiplex® (R&D Systems, Minnesota, MN, USA). Serum levels of LBP will be measured using a commercial enzyme-linked immunosorbent assay (HK315-02, HyCult Biotech Inc., Uden, the Netherlands) as per manufacturer's instructions. The intra- and inter-assay coefficients of LBP variation are <5 and <10%, respectively. Besides, serum from 40 normal control subjects will be used for interassay variation. Both the intra- and the interassay coefficients of variation were <8.0%. All samples will be measured in duplicates and the mean value is reported in μg/mL

Percent fat is measured with Bioelectric Impedance Spectroscopy

Whole-body bioelectric impedance spectroscopy (BIS) measurement using a body composition monitor (BCM: Fresenius Medical Care, Bad Homburg, Germany) is performed on each of the participants enrolled in the study as described previously [28]. Briefly, measurements were taken on the day before dialysis with the patient calm, supine, and relaxed in the dialysis bed for 10 minutes. Four electrodes were placed on the patient's hand and foot on the side contra lateral to their arteriovenous fistula. The basic principle of this machine is the use of the bioimpedance spectroscopy which determines the fluid content of the body by measuring the serial values of electric impedance by applying small microAmp electric currents at 50 different frequencies between 5 and 1000 kHz. These impedance data are used to obtain the amount of total body water, intracellular water and extracellular water through a special fluid model and information about other body compositions, such as fat tissue or lean tissue, through a physiological body composition model [29]. The major estimates the body composition measured by BCM-BIS are as follows: (1) lean tissue mass (LTM -mainly muscle), fat mass (FAT), and adipose tissue mass (ATM-mainly fat with its relevant hydration)

Measurement of arterial stiffness

Arterial stiffness is evaluated by measuring PWV in the heart-femoral segment using an automatic waveform analyzer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Tungs' Taichung Metroharbour Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months.

Description

Inclusion Criteria:

  1. Both sexes aged between 20-90 years.
  2. Received stable hemodialysis at least 3 months.
  3. Written informed consent.

Exclusion Criteria:

  1. patients with severe infections, severe heart disease and liver disease, malignancy, autoimmune disorders, severe malnutrition, or clinical conditions requiring oral nutrition supplements;
  2. Inability to follow protocol.
  3. Pregnancy or wishing/trying to get pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Atherosclerotic events
Time Frame: 3 years
Incident atherosclerotic vascular events in HD patients
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 3 years
The association of LBP with all-cause mortality
3 years
Association with inflammatory markers
Time Frame: 3 years
TNF-alpha, Interleukin-10(IL-10), Interleukin-6 (IL-6) and soluble (sCD14) are measured using an enzyme-linked immunosorbent assay (ELISA) annually
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tungs' Taichung Metroharbour Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 106064

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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