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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04804436
Other study ID # Geneticstone
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date October 6, 2019

Study information

Verified date March 2021
Source Saglik Bilimleri Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the present study investigators aimed to investigate whether homeodomain interacting protein kinase 2 (HIPK2) polymorphism is associated with renal stone formation in Turkish population or not. One hundred and twenty nine participants with calcium nephrolithiasis and 67 sex and age-matched healthy controls were enrolled in this study. For analysis of HIPK2 polymorphism, the real-time PCR amplification was performed in a final volume of 20μL reaction mixture, including 10 ng of genomic DNA, 5 µL of TaqMan® Universal PCR Master Mix, and 0.5 µL of 40X TaqMan® assay. The Rotor-Gene Q Series Software Version Q 2.3.1 (Rotor-Gene Q Series, Ziagen) was used for allelic discrimination. Chi square test was utilized to compare the differences of the genotype and allele frequencies between patients and controls.


Description:

Kidney stone incidence depends on geographical, climatic, ethnic, dietary and genetic factors. Thus the prevalence rates for urinary stones change from 1% to 20%. 1,2 Genetic polymorphism also causes nephrolithiasis. The most known polymorphic genes are the calcium-sensing receptor (CASR), vitamin D receptor (VDR), and matrix gla protein (MGP), plasminogen activator, urokinase (PLAU). 3,4 Furthermore, the concordance rate of the stone disease in monozygotic twins is substantially higher than in dizygotic ones (32.4% vs. 17.3%) demonstrating that genetic factors play a vital role in the formation of nephrolithiasis. 5 Homeodomain interacting protein kinase 2 (HIPK2) has been shown to be a new androgen receptor regulator. HIPK2 and androgen were demonstrated to mediate kidney tubular epithelial cell injury and apoptosis. Informations on HIPK2 polymorphism about renal stone formation are newfound and inconclusive. Therefore, in this study, authors aimed to investigate whether HIPK2 polymorphism is associated with renal stone formation in Turkish population or not.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date October 6, 2019
Est. primary completion date October 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 38 Years to 68 Years
Eligibility Inclusion Criteria: Patients with nephrolithiasis Exclusion Criteria: - Patients had a history of chronic urinary tract infection - renal failure - gastrointestinal diseases - increased levels of vitamin D - sarcoidosis - primary hyperoxaluria - polycystic kidney disease, gout, renal tubular acidosis, primary and secondary hyperparathyroidism.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Genetic analysis
he real-time PCR amplification was performed in a final volume of 20µL reaction mixture, including 10 ng of genomic DNA, 5 µL of TaqMan® Universal PCR Master Mix, and 0.5 µL of 40X TaqMan® assay. Thermal cycling conditions were as follows: initial denaturation at 94? for 3 min, 40 cycles of 94? for 15 s, and 60°C for 1 min. The Rotor-Gene Q Series Software Version Q 2.3.1 (Rotor-Gene Q Series, Ziagen) was used for allelic discrimination.

Locations

Country Name City State
Turkey Omer Gokhan Doluoglu Ankara

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Single nucleotide polymorphism Single nucleotide polymorphism incidence on rs2058265, rs6464214, and rs7456421 One year
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