Changes of Muramyl Dipeptide in Intestinal and Extra-intestinal Diseases

• Conditions: Inflammatory Bowel Disease; Atherosclerotic Cardiovascular Disease; Type2 Diabetes Mellitus; Colorectal Cancer
• Interventions: Other: Observational studies, no intervention

• Registration Number: NCT04924686
• Lead Sponsor: Zhujiang Hospital

Brief Summary

Nucleotide-binding oligomerization domain 2 (Nod2) signaling is critical for human health.To figure out the clinical relevance of NOD2 ligands, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes mellitus (DM2 ).

Detailed Description

Previous studies have shown that NOD2 gene mutants were associated with the Crohn's disease (CD), colorectal cancer (CRC) and many other diseases, suggesting the critical role of NOD2 signaling in human physiology and pathogenethesis. However, whether decreased NOD2 ligands also contributed to these diseases is unknown. In this study, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes mellitus (DM2 ). For each of the patient, a sex- and age- matched control were chosen. Both the targeted metabolomics (LC-MS-MS methods) and NOD2-transfected cells co-expressing NF-κB luciferase reporters were used to test NOD2 ligands in the fecal and plasma samples.

Study Timeline

• Study Start: 2020-05-10
• Status Verified: 2021-06
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-10
• Last Update Submitted: 2021-06-10
• Study First Posted: 2021-06-14
• Last Update Posted: 2021-06-14
• Primary Completion: 2023-06-10
• Study Completion: 2023-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Males or females at least 18-70 years old.
2. Patient able to give informed consent.
3. Patient with biopsy-proven CRC
4. Patient with biopsy-proven Crohn's disease (CD) or ulcerative colitis(UC), in the active phase.
5. patients with clinical diagnosed DM2
6. patients with ACVD:coronary angiography more than 50% stenosis in single or multiple vessels.
7. The age- and sex- matched health controls for each patient.

Exclusion Criteria

1.Use antibiotics or probiotics within the last 2 weeks.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crohn's disease	Observational studies, no intervention	The fecal and plasma were collected
Ulcerative colitis	Observational studies, no intervention	The fecal and plasma were collected
Diabetes mellitus, type 2	Observational studies, no intervention	The fecal and plasma were collected
Atherosclerotic cardiovascular disease	Observational studies, no intervention	The fecal and plasma were collected
Colorectal cancer	Observational studies, no intervention	The fecal and plasma were collected

Primary Outcome Measures

Name	Time	Method
NOD2 ligands in fecal and plasma	baseline	detected using targeted metabolomics (LC-MS-MS methods) and NOD2-transfected cells co-expressing NF-κB luciferase reporters

Trial Locations

Locations (1)

Zhujiang hospital; 🇨🇳 Guangzhou, Guang Dong, China