Acute Rheumatic FeverNCT01886846
Plasma Adiponectin Levels and Relations With Cytokines in Children With Acute Rheumatic Fever
An observational study of Acute Rheumatic Fever, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Rheumatic Fever
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2008to Aug 2010
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi Universty
Eskişehir, Odunpazarı, 26480
About this study
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.
Read the detailed description
Totally, 33 children (age range: 5 - 17 years; 15 male and 18 female) were enrolled to the study who were diagnosed as ARF at the Pediatric Cardiology Department, Medical Faculty, Eskişehir Osmangazi University. The study protocol was approved by Ethics Committee of Medical Faculty, Eskişehir Osmangazi University (Decision No. 41 dated June 4, 2008). Parents of study participants were informed about the aim and the method of the study and written consents were obtained.
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.
Venous Blood Sampling Following tests were analyzed using venous blood samples drawn from patients and healthy control subjects; complete blood count, ESR, nephelometric CRP and immune turbidimetric hsCRP, total cholesterol, triglyceride, LDL-C and HDL-C levels by enzymatic coloxrimetric method and FSH and LH and total testosterone (for male subjects) and estradiol (for female subjects)levels by chemoluminescent assey. Plasma and serum samples were drawn for adiponectin, TNF-α, IL-6 and IL-8. Blood samples were drawn for analyzing acute phase reactants at Day 2nd , 5th , 10th and 15th days and at 8 week in order to evaluate response to the treatment, while blood samples were simultaneously drawn for analyzing adiponectin, TNF-α, IL-6 and IL-8 levels.
Plasma Adiponectin Measurement Venous blood samples were added into the centrifuge tubes with EDTA, they were centrifuged at 3000 rpm, 4 °C for 15 minutes and the resultant plasma samples were stored at -80 °C. Plasma samples were diluted (1:300) as directed by the instruction for use of the kit, before the analysis was conducted. Samples taken for plasma adiponectin levels were analyzed using Human Adiponectin ELISA, High Sensitivity kit (BioVendor Research and Diagnostic Products, Modrice, Czech Republic) with enzyme-linked immunosorbent assay (ELISA) method. Absorbance was read at 450 nm. Results were expressed as ng/ml and converted into µg/ml via dividing them by 1000.
Serum TNF-α, IL-6 and IL-8 Measurements The venous blood samples were added into centrifuge tubes not containing anticoagulant for measuring serum TNF-α, IL-6 and IL-8 levels. Samples were centrifuged at 3000 rpm, 4 °C for 15 minutes and the resultant serum samples were stored at -80 °C. Samples taken for measuring serum TNF-, IL-6 and IL-8 levels were analyzed with ELISA method using Human TNF-α ELISA, Human IL-6 ELISA, Human IL-8/NAP-1 ELISA kits (Bender MedSystems, Vienna, Austria). Absorbance was read at 450 nm. Results were expressed as pg/ml.
- Conditions
- Acute Rheumatic Fever
- Medical subject headings
- Rheumatic Fever
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline adiponectin and cytokin levels at 2 months in the acute rheumatic fever
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJul 2008
- Primary completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Rheumatic FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ali Yildirim, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886846
- Sponsor's protocol ID
- EskisehirOU 4.6.2008/41
- Status last verified
- Jun 2013
- First submitted
- 19 Jun 2013
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17343838
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Adiponectin Levels and Relations With Cytokines in Children With Acute Rheumatic Fever
- ClinicalTrials.gov ID
- NCT01886846
- Acronym / sponsor ID
- EskisehirOU 4.6.2008/41
- Conditions
- Acute Rheumatic Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Aug 2010 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Totally, 33 children (age range: 5 - 17 years; 15 male and 18 female) were enrolled to the study who were diagnosed as ARF at the Pediatric Cardiology Department, Medical Faculty, Eskişehir Osmangazi University. The study protocol was approved by Ethics Committee of Medical Faculty, Eskişehir Osmangazi University (Decision No. 41 dated June 4, 2008). Parents of study participants were informed about the aim and the method of the study and written consents were obtained.
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.
Venous Blood Sampling Following tests were analyzed using venous blood samples drawn from patients and healthy control subjects; complete blood count, ESR, nephelometric CRP and immune turbidimetric hsCRP, total cholesterol, triglyceride, LDL-C and HDL-C levels by enzymatic coloxrimetric method and FSH and LH and total testosterone (for male subjects) and estradiol (for female subjects)levels by chemoluminescent assey. Plasma and serum samples were drawn for adiponectin, TNF-α, IL-6 and IL-8. Blood samples were drawn for analyzing acute phase reactants at Day 2nd , 5th , 10th and 15th days and at 8 week in order to evaluate response to the treatment, while blood samples were simultaneously drawn for analyzing adiponectin, TNF-α, IL-6 and IL-8 levels.
Plasma Adiponectin Measurement Venous blood samples were added into the centrifuge tubes with EDTA, they were centrifuged at 3000 rpm, 4 °C for 15 minutes and the resultant plasma samples were stored at -80 °C. Plasma samples were diluted (1:300) as directed by the instruction for use of the kit, before the analysis was conducted. Samples taken for plasma adiponectin levels were analyzed using Human Adiponectin ELISA, High Sensitivity kit (BioVendor Research and Diagnostic Products, Modrice, Czech Republic) with enzyme-linked immunosorbent assay (ELISA) method. Absorbance was read at 450 nm. Results were expressed as ng/ml and converted into µg/ml via dividing them by 1000.
Serum TNF-α, IL-6 and IL-8 Measurements The venous blood samples were added into centrifuge tubes not containing anticoagulant for measuring serum TNF-α, IL-6 and IL-8 levels. Samples were centrifuged at 3000 rpm, 4 °C for 15 minutes and the resultant serum samples were stored at -80 °C. Samples taken for measuring serum TNF-, IL-6 and IL-8 levels were analyzed with ELISA method using Human TNF-α ELISA, Human IL-6 ELISA, Human IL-8/NAP-1 ELISA kits (Bender MedSystems, Vienna, Austria). Absorbance was read at 450 nm. Results were expressed as pg/ml.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- acute rheumatic fever and by comparing results with that of healthy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline adiponectin and cytokin levels at 2 months in the acute rheumatic fever
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
- Background: PubMed 17343838Ouchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Rheumatic Fever, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline adiponectin and cytokin levels at 2 months in the acute rheumatic fever (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.