Not yet recruitingNCT06680076Updated Dec 12, 2024

Study on Lipid Profile Changes in Plasma and Intestinal Mucosa of Patients With Inflammatory Bowel Disease

An observational study in Inflammatory Bowel Diseases, sponsored by First Affiliated Hospital of Harbin Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by First Affiliated Hospital of Harbin Medical University · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 90
Ages: 18 Years to 80 Years
Sex: All

Study summary

This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease.

Read the detailed description

This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease.

The investigators followed up with patients with different stages of IBD and collected plasma and lesion tissues from patients and healthy volunteers for lipid metabolism-related substances to assess the changes in lipid metabolism in patients with different stages of IBD and their impact on disease.

Conditions studied

Inflammatory Bowel Diseases

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Keywords

IBD
lipid metabolism
activity

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Healthy volunteers and patients who have inflammation bowel disease.

Inclusion criteria

Patients with inflammatory bowel disease; aged 18-80 years; all cases agreed to participate in the study.
Healthy volunteers who agreed to participate in the study.

Exclusion criteria

Exclusion Criteria:

Patients with severe heart disease; patients with severe kidney disease; patients with low blood pressure; patients with severe infections such as sepsis or pneumonia; patients who have used immunosuppressants such as 6-mercaptopurine, imidazole thiopurine, and cyclosporine within a short period, and women during pregnancy; patients who are post-colon resected; patients who disagreed to participate in the study.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 90 participants (estimated)
Patient registry: No
Biospecimen retention: Samples without dna

Groups and cohorts

Disease group
Patients who have inflammation bowel disease.
Health group
Healthy people who volunteered to participate.

What researchers measure

Primary outcomes

Differential lipid composition between disease and healthy groups
Differences in lipid composition between disease and healthy groups.
Time frame: 14 weeks
Differences in lipid composition between active and remission disease
Differences in lipid composition between active and remission disease
Time frame: 14 weeks

Study locations

1 site

Carol
Harbin, Heilongjiang 150001, China
- Huichao D Zhang · Contact · zhanghuichao0609@163.com · 13945003159

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT06680076
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Responsible party: Hongyu Xu (Chief of the GI department, First Affiliated Hospital of Harbin Medical University) — Principal investigator
First posted: Nov 8, 2024
Start date: Dec 2024 (estimated)
Primary completion: Feb 25, 2025 (estimated)
Completion: Mar 30, 2025 (estimated)
Last update: Dec 12, 2024

Study contacts

Huichao Zhang, MD

Contact

zhanghuichao0609@163.com

13945003159 ext. 0451-85555119

Hongyu D Xu, PHD

study director · Harbin Medical University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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