Viewing Study NCT01830725



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Last Modification Date: 2024-10-26 @ 11:05 AM
Study NCT ID: NCT01830725
Status: COMPLETED
Last Update Posted: 2016-08-30
First Post: 2013-04-05

Brief Title: Purine Metabolism Enzyme SNP to Uric Acid Production
Sponsor: Keesler Air Force Base Medical Center
Organization: Keesler Air Force Base Medical Center

Study Overview

Official Title: Relationship of Purine Metabolism Enzyme Single-Nucleotide Polymorphisms to Uric Acid Production and Response to Xanthine Oxidase Inhibitors
Status: COMPLETED
Status Verified Date: 2016-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Determine whether a relationship exists between polymorphisms of the genes XDH HPRT1 and PRPS1 and gout hyperuricemia or the dose of xanthine oxidase XO inhibitors to reach a goal serum uric acid of less than 6 mgdL This study is observational in nature as no dose adjustment of XO inhibitors will be made by study investigators
Detailed Description: Background Our recent gout study demonstrated a relationship between the xanthine oxidase XO single nucleotide polymorphism SNP 2107AG to the dose of allopurinol needed to reach a goal serum uric acid level of 6 mgdL or less This study had some limitations but suggests that specific SNPs could be related to dose of allopurinol needed to treat

Objective To determine the relationship of multiple purine enzyme SNPs of genes encoding PRPS1 HPRT1 and XO to the dose of xanthine oxidase inhibitor needed to achieve a goal treatment uric acid level of less than 6 mgdL Another primary outcome will be to determine relationship of two XO SNPs to hyperuricemiagout A secondary outcome will be to determine the frequency of these SNPs tested

Design Patients will be consented for enrollment in either the gouthyperuricemia group or a control group Control group patients will have neither gout nor hyperuricemia No patients will be enrolled if they are overproducers of uric acid It is anticipated that 200 patients will be enrolled in each group for a total of 400 patients over the next 2 years

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None