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

Sponsor

West China Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03842371

Collaborator

(none)

Enrollment

36.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Syndrome	Other: Metabolic level of BCAAs in monocytes and macrophages

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 Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Feb 11, 2019

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Plasma levels of branched-chain amino acids [1,3,5,7,10,14 day after diagnose of sepsis]
BCAAs Assay Kit will be used to measure the plasma levels of BCAAs.
The expression of branched-chain amino acid aminotransferase in monocytes [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.
The expression of branched-chain α-ketoacid dehydrogenase in monocytes [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.
The expression of PP2Cm in monocytes [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.
The plasma level of IL-1β [1,3,5,7,10,14 day after diagnose of sepsis.]
The plasma level of IL-1β will be determined by ELISA kit.
The plasma level of TNF-α [1,3,5,7,10,14 day after diagnose of sepsis.]
The plasma level of TNF-α will be determined by ELISA kit.
The plasma level of IL-10 [1,3,5,7,10,14 day after diagnose of sepsis.]
The level of IL-10 will be determined by ELISA kit.
The plasma level of chemokine MIP-1α. [1,3,5,7,10,14 day after diagnose of sepsis.]
The plasma level of chemokine MIP-1α will be determined by ELISA kit.
The plasma level of chemokine MIP-1β. [1,3,5,7,10,14 day after diagnose of sepsis.]
The plasma level of chemokine MIP-1β will be determined by ELISA kit.
The phagocytic index of monocytes. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

West China Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chunling Jiang, Clinical Professor, West China Hospital

ClinicalTrials.gov Identifier:

NCT03842371

Other Study ID Numbers:

2018-081

First Posted:

Feb 15, 2019

Last Update Posted:

Feb 15, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sepsis

Toxemia

Systemic Inflammatory Response Syndrome

Study Results

No Results Posted as of Feb 15, 2019