Clinical trial NCT04924686: Changes of Muramyl Dipeptide in Intestinal and Extra-intestinal Diseases
Official title: A Bacterial Bi-functional Peptidoglycan Hydrolase Sheds NOD2 Ligands to Regulate Gut Homeostasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Inflammatory Bowel Disease
Atherosclerotic Cardiovascular Disease
Type2 Diabetes Mellitus
Keywords: NOD2 ligands
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2021-06-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with IBD, CRC, ACVD or DM2 hospitalized in Zhujiang hospital will be eligible to be enrolled. Also, their age- and sex- matched healthy controls making a physical examination in Zhujiang hospital will be eligible to be enrolled

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.

Eligibility criteria: 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.

Primary outcomes:
measure: NOD2 ligands in fecal and plasma
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang hospital
state: Guang Dong
Study officials:
affiliation: Zhujiang Hospital, Guangzhou, Guangdong
name: Hongwei Zhou, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Philpott DJ, Sorbara MT, Robertson SJ, Croitoru K, Girardin SE. NOD proteins: regulators of inflammation in health and disease. Nat Rev Immunol. 2014 Jan;14(1):9-23. doi: 10.1038/nri3565. Epub 2013 Dec 13.