- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04804436
Protein Kinase 2 (HIPK2) Polymorphisms on rs2058265, rs6464214, and rs7456421
Do Homeodomain Interacting Protein Kinase 2 (HIPK2) Polymorphisms rs2058265, rs6464214, and rs7456421 Associate With Nephrolithiasis in Turkish Population?
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.
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey
- Omer Gokhan Doluoglu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with nephrolithiasis
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.
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.
|
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.
|
Experimental: Healthy control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Single nucleotide polymorphism
Time Frame: One year
|
Single nucleotide polymorphism incidence on rs2058265, rs6464214, and rs7456421
|
One year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Cavit Ceylan, Professor, University of Medical Sciences, Ministry of Health, Ankara City Hospital, Department of Urology, Ankara, Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Geneticstone
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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