Metabolism of Branched-chain Amino Acids in Monocyte/Macrophage During Sepsis

February 14, 2019 updated by: Chunling Jiang, West China Hospital

Metabolism of Branched-chain Amino Acids in Monocyte and Macrophage During Sepsis

The current project was designed to examine the metabolic level of branched-chain amino acids in plasm and monocyte/macrophage, and its role in immune dysfunction during sepsis.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, the investigators will collect the peripheral blood of 1,3,7,14 day after diagnose of sepsis. Then, the concentration of branched-chain amino acids(BCAAs) in monocytes and plasma, and the expression of BCAAs metabolic enzymes in monocytes will be determined. Additionally, the inflammatory cytokines, e.g., Interleukin-1β (IL-1β), Tumor necrosis factor-α (TNF-α), Interleukin-10 (IL-10）, the chemokines macrophage inflammatory proteins 1α and 1β (MIP-1α and 1β) in the peripheral blood and the phagocytic function of monocytes will also be detected. The current project was designed to examine the metabolic level of branched-chain amino acids in plasm and monocyte/macrophage, and its role in immune dysfunction during sepsis.

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 (Anticipated)

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.
90

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who are diagnosed as sepsis, with or without type 2 diabetes.

Description

Inclusion Criteria:

  • patients diagnosed with sepsis, with or without type 2 diabetes
  • healthy volunteers

Exclusion Criteria:

  • patients with immunodeficient diseases
  • patients who accept glucocorticoid or immunosuppressant
  • patients with an age younger than 18 years
  • patients who cannot provide the informed consent

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sepsis with type 2 diabetes
Sepsis patients with type 2 diabetes
Other: Metabolic level of BCAAs in monocytes and macrophages
Metabolic level of BCAAs in monocytes and macrophages
Sepsis without type 2 diabetes
Sepsis patients without type 2 diabetes
Other: Metabolic level of BCAAs in monocytes and macrophages
Metabolic level of BCAAs in monocytes and macrophages
Volunteers
Healthy volunteers
Other: Metabolic level of BCAAs in monocytes and macrophages
Metabolic level of BCAAs in monocytes and macrophages

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
Intracellular levels of branched-chain amino acids in monocytes
Time Frame: up to 14 day after diagnose of sepsis
BCAAs Assay Kit will be used to measure the intracellular levels of BCAAs in monocytes.
up to 14 day after diagnose of sepsis

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
Plasma levels of branched-chain amino acids
Time Frame: 1,3,5,7,10,14 day after diagnose of sepsis
BCAAs Assay Kit will be used to measure the plasma levels of BCAAs.
1,3,5,7,10,14 day after diagnose of sepsis
The expression of branched-chain amino acid aminotransferase in monocytes
Time Frame: 1,3,5,7,10,14 day after diagnose of sepsis
The expression of branched-chain amino acid aminotransferase in monocytes will be determined by qPCR and western blot.
1,3,5,7,10,14 day after diagnose of sepsis
The expression of branched-chain α-ketoacid dehydrogenase in monocytes
Time Frame: 1,3,5,7,10,14 day after diagnose of sepsis
The expression of branched-chain α-ketoacid dehydrogenase in monocytes will be determined by qPCR and western blot.
1,3,5,7,10,14 day after diagnose of sepsis
The expression of PP2Cm in monocytes
Time Frame: 1,3,5,7,10,14 day after diagnose of sepsis
The expression of mitochondrial-targeted phosphatase, PP2Cm in monocytes will be determined by qPCR and western blot.
1,3,5,7,10,14 day after diagnose of sepsis
The plasma level of IL-1β
Time Frame: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of IL-1β will be determined by ELISA kit.
1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of TNF-α
Time Frame: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of TNF-α will be determined by ELISA kit.
1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of IL-10
Time Frame: 1,3,5,7,10,14 day after diagnose of sepsis.
The level of IL-10 will be determined by ELISA kit.
1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of chemokine MIP-1α.
Time Frame: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of chemokine MIP-1α will be determined by ELISA kit.
1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of chemokine MIP-1β.
Time Frame: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of chemokine MIP-1β will be determined by ELISA kit.
1,3,5,7,10,14 day after diagnose of sepsis.
The phagocytic index of monocytes.
Time Frame: 1,3,5,7,10,14 day after diagnose of sepsis.
The phagocytic index of monocytes will be determined by a E.coli Phagocytosis Assay Kit.
1,3,5,7,10,14 day after diagnose of sepsis.

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.
West China 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 (Anticipated)

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.
February 11, 2019

Primary Completion (Anticipated)

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 30, 2021

Study Completion (Anticipated)

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.
February 28, 2022

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).
February 8, 2019

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 14, 2019

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 15, 2019

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.
February 15, 2019

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.
February 14, 2019

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.
February 1, 2019

More Information

Terms related to this study

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.
  • 2018-081 (Registry Identifier: METC ErasmusMC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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