Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01886846 |
| Other study ID # |
EskisehirOU 4.6.2008/41 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 19, 2013 |
| Last updated |
June 22, 2013 |
| Start date |
July 2008 |
Study information
| Verified date |
June 2013 |
| Source |
Eskisehir Osmangazi University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Turkey: Ethics Committee |
| Study type |
Observational [Patient Registry]
|
Clinical 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 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.
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.
