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Protein Kinase 2 (HIPK2) Polymorphisms on rs2058265, rs6464214, and rs7456421

Primary Purpose

Kidney Stone

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Genetic analysis
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Kidney Stone focused on measuring KSD HIPK2 gene Polymorphism

Eligibility Criteria

38 Years - 68 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Omer Gokhan Doluoglu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with nephrolithiasis

Healthy control group

Arm Description

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.

Outcomes

Primary Outcome Measures

Single nucleotide polymorphism
Single nucleotide polymorphism incidence on rs2058265, rs6464214, and rs7456421

Secondary Outcome Measures

Full Information

First Posted
March 14, 2021
Last Updated
March 17, 2021
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT04804436
Brief Title
Protein Kinase 2 (HIPK2) Polymorphisms on rs2058265, rs6464214, and rs7456421
Official Title
Do Homeodomain Interacting Protein Kinase 2 (HIPK2) Polymorphisms rs2058265, rs6464214, and rs7456421 Associate With Nephrolithiasis in Turkish Population?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
October 6, 2019 (Actual)
Study Completion Date
October 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
KSD HIPK2 gene Polymorphism

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with nephrolithiasis
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy control group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Genetic
Intervention Name(s)
Genetic analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Single nucleotide polymorphism
Description
Single nucleotide polymorphism incidence on rs2058265, rs6464214, and rs7456421
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cavit Ceylan, Professor
Organizational Affiliation
University of Medical Sciences, Ministry of Health, Ankara City Hospital, Department of Urology, Ankara, Turkey
Official's Role
Study Director
Facility Information:
Facility Name
Omer Gokhan Doluoglu
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Protein Kinase 2 (HIPK2) Polymorphisms on rs2058265, rs6464214, and rs7456421

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