Calprotectin and Ischemia Modified Albumin Serum to Measure Disease Activity in Behçet's Disease

Completed

• Conditions: Behçet's Diseasecases
• Interventions: Diagnostic Test: Serum calprotectin and IMA concentrations

• Registration Number: NCT05868538
• Lead Sponsor: Mansoura University

Brief Summary

Behçet's Disease activity was evaluated using BD Current Activity Form (BDCAF). Serum calprotectin and IMA concentrations were compared among active BD cases, inactive BD cases and control subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-15
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-18
• Last Update Submitted: 2023-05-18
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• new case of Behçet's disease available medical record Well known duration of BD, Well known current treatment used Well known current organ involvement

Exclusion Criteria

• concomitant autoimmune or auto-inflammatory disorder; acute or chronic infections; cancer; diabetes; heart failure; gestation or up to six months after birth

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Serum calprotectin and IMA concentrations	-
control	Serum calprotectin and IMA concentrations	-

Primary Outcome Measures

Name	Time	Method
BD activity was evaluated using BD Current Activity Form (BDCAF).	3 years	BD activity was assessed with BDCAF which assesse clinical characteristics present during the previous one month before evaluation. BDCAF include the following components: headaches; mouth ulcers; erythema; genital ulcers; arthritis; arthralgia; nausea/emesis/pain in abdomen; rectal bleeding; diarrhea; and new ocular, vascular, and nervous symptoms. Each component takes a score of (0) if absent or (1) if present \[30\]. The total BDCAF score was calculated by adding up the positive components (maximum score = 12). A BDCAF patient index score ≥2 was considered as active BD, while a score less than 2 was considered as inactive BD
Ischaemia Modified Albumin (IMA) serum concentrations	3 years	IMA was quantified based on albumin cobalt binding colorimetric assay according to Bar-Or and colleagues and the levels were expressed in absorbance units (ABSU). To obtain corrected IMA values, the equation (individual albumin level/median albumin level of population) × IMA ABSU value was applied. Unit of measurment ( kU/L)
Serum calprotectin concentrations	3 years	Blood samples were withdrawn from all participants 12 h after fasting. Samples underwent centrifugation at 4000 rpm for ten minutes. The sera were collected and kept at -80°C till analysis.; Serum calprotectin concentrations were quantified utilizing a commercial calprotectin ELISA kit (Hycult Biotech Inc, US) based on manufacturer's instructions. Levels of high-sensitivity CRP (hsCRP) and albumin were detected using the immunoturbidimetric technique. Unit of measurment (μg/ml )

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Egypt