NCT01886846

Brief Summary

We aimed to investigate if adiponectin facilitates diagnosis of ARF by analyzing adiponectin levels in acute and convalescent periods of the acute rheumatic fever and by comparing results with that of healthy control group; also by comparatively examining levels of adiponectin in ARF cases who had different clinical findings at presentation. In addition, we aimed to investigate its role in the pathogenesis of ARF by evaluating correlations with cytokines such as TNF-α, IL-6 and IL-8 and acute phase reactants.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

2.1 years

First QC Date

June 19, 2013

Last Update Submit

June 22, 2013

Conditions

Acute Rheumatic Fever

Outcome Measures

Primary Outcomes (1)

  • Change from baseline adiponectin and cytokin levels at 2 months in the acute rheumatic fever

    2 months

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

acute rheumatic fever and by comparing results with that of healthy

For the study subjects, diagnosis of ARF was made according to the Modified Jones criteria (4) and appropriate treatment was started. Patients were divided into three groups by clinical findings. Group 1 included patients with only chorea, while patients with arthritis and carditis were involved in Group 2 and patients with only carditis were included in the Group 3. A group with only arthritis was not established since the patients with isolated arthritis are usually followed up at primary and secondary healthcare facilities rather than referring those patients to our tertiary healthcare center.

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Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi Universty

Eskişehir, Odunpazarı, 26480, Turkey (Türkiye)

Location

Related Publications (1)

  • Ouchi N, Walsh K. Adiponectin as an anti-inflammatory factor. Clin Chim Acta. 2007 May 1;380(1-2):24-30. doi: 10.1016/j.cca.2007.01.026. Epub 2007 Feb 2.

    PMID: 17343838BACKGROUND

MeSH Terms

Conditions

Rheumatic Fever

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow in Pediatric Cardiology, MD

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 26, 2013

Study Start

July 1, 2008

Primary Completion

August 1, 2010

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

TU(1)