Study on Lipid Profile Changes in Plasma and Intestinal M... | NCT06680076

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

NCT06680076

Sponsor

First Affiliated Hospital of Harbin Medical University

Status

Not yet recruiting

Last Update Posted

Dec 12, 2024Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Inflammatory Bowel Diseases

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2024Estimated

Primary Completion Date

Feb 25, 2025Estimated

Completion Date

Mar 30, 2025Estimated

First Submitted Date

Nov 6, 2024

First Submission Date that Met QC Criteria

Nov 6, 2024

First Posted Date

Nov 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2024

Last Update Posted Date

Dec 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hongyu Xu, Chief of the GI department, First Affiliated Hospital of Harbin Medical UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Harbin Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Disease group		Patients who have inflammation bowel disease.
Health group		Healthy people who volunteered to participate.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differential lipid composition between disease and healthy groups	Differences in lipid composition between disease and healthy groups.	14 weeks
Differences in lipid composition between active and remission disease	Differences in lipid composition between active and remission disease	14 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers and patients who have inflammation bowel disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Huichao Zhang, MD	Contact	13945003159	0451-85555119	zhanghuichao0609@163.com

Overall Officials

Name	Affiliation	Role
Hongyu D Xu, PHD	Harbin Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carol		Harbin	Heilongjiang	150001	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D009043	Motor Activity

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided