Galectin-3 Level in Ankylosing Spondylitis Patients | NCT04746196

Studies
Galectin-3 Level in Ankylosing Spondylitis Patients

NCT04746196

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Status

Completed

Last Update Posted

Apr 20, 2021Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Ankylosing Spondylitis

Interventions

Serum galectin-3 concentration was measured.

Countries

Not provided

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Aug 30, 2017Actual

First Submitted Date

Feb 4, 2021

First Submission Date that Met QC Criteria

Feb 8, 2021

First Posted Date

Feb 9, 2021Actual

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

Apr 17, 2021

Last Update Posted Date

Apr 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gul Devrimsel, Clinical Professor, Recep Tayyip Erdogan University Training and Research HospitalPrincipal Investigator

Lead Sponsor

Recep Tayyip Erdogan University Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Forty-five AS patients and 35 healthy controls were enrolled in this study. Patients diagnosed with AS according to Modified New York criteria were included in the study. Clinical and laboratory measurements, duration of symptoms, age and body mass index (BMI) of AS patients were performed and compared with age and BMI matched control group.

Detailed Description

Detailed histories of all participants were obtained, and systemic and rheumatologic examinations were performed. We excluded all participants who had a history of hyperlipidemia, liver, renal, hematological, familial thyroid, neoplastic, autoimmune infectious diseases and receiving anti-inflammatory drugs.

We measured serum galectin-3 levels using a commercial chemiluminescent microparticle immunoassay. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to assess disease activity in AS patients.

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

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
45 ankylosing spondylitis patients.		Patients diagnosed with ankylosing spondylitis according to Modified New York criteria were included in the study.	Other: Serum galectin-3 concentration was measured.
35 controls		Healthy controls	Other: Serum galectin-3 concentration was measured.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum galectin-3 concentration was measured.	Other	Serum galectin-3 concentration was measured using a commercial chemiluminescent microparticle immunoassay.	35 controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relationship Between Galectin-3 Level and Disease Activity in Ankylosing Spondylitis Patients	Correlation	5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ankylosing spondylitis patients
Healthy controls

Exclusion Criteria:

Hyperlipidemia
Liver diseases
Renal diseases
Hematological diseases
Familial thyroid diseases
Neoplastic diseases
Autoimmune infectious diseases
Receiving anti-inflammatory drugs.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Ankylosing spondylitis patients and healthy controls

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013167	Spondylitis, Ankylosing

Ancestor Terms

ID	Term
D000089183	Axial Spondyloarthritis
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis

Browse Leaves

Not provided

Browse Branches

Not provided