Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001036000
Ethics application status
Approved
Date submitted
23/11/2010
Date registered
24/11/2010
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Finding the Genes for Gout: the effect of fructose
Scientific title
The influence of genetic variants on fructose-induced hyperuricaemia
Secondary ID [1] 253146 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperuricaemia 258697 0
Gout 258707 0
Condition category
Condition code
Metabolic and Endocrine 258849 258849 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A sugar solution of 300kcal/300ml will be administered to all participants. This solution will contain 80% fructose and 20% glucose (64g fructose and 16g glucose). Participants will then be observed for three hours.
Intervention code [1] 257652 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259702 0
Change in serum urate concentration following a fructose challenge (blood test)
Timepoint [1] 259702 0
30 minutes, 60 minutes, 120 minutes, and 180 minutes after ingestion
Secondary outcome [1] 266421 0
Change in fractional excretion of urate to 3 hours following a fructose challenge (blood and urine test)
Timepoint [1] 266421 0
30 minutes, 60 minutes, 120 minutes, and 180 minutes after ingestion

Eligibility
Key inclusion criteria
Able to provide written informed consent
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a. History of gout
b. History of diabetes mellitus
c. History of fructose intolerance
d. Diuretic use
e. Fasting capillary glucose >6mmol/L

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
6/10/2011
Date of last participant enrolment
Anticipated
29/02/2012
Actual
29/02/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
76
Recruitment outside Australia
Country [1] 3063 0
New Zealand
State/province [1] 3063 0
Auckland

Funding & Sponsors
Funding source category [1] 258119 0
Government body
Name [1] 258119 0
Health Research Council of New Zealand
Country [1] 258119 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
PO Box 5541, Wellesley Street, Auckland, 1141, New Zealand
Country
New Zealand
Secondary sponsor category [1] 257297 0
None
Name [1] 257297 0
Address [1] 257297 0
Country [1] 257297 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260103 0
Multiregion Ethics Committee
Ethics committee address [1] 260103 0
PO Box 5013
Wellington
Ethics committee country [1] 260103 0
New Zealand
Date submitted for ethics approval [1] 260103 0
Approval date [1] 260103 0
27/07/2010
Ethics approval number [1] 260103 0
MEC/05/10/130

Summary
Brief summary
We have previously identified genetic variation in a urate transporter gene SLC2A9 as a key risk factor for development of gout in those of Maori, Pacific and Caucasian ancestry. This transporter is also a fructose transporter and in vitro assays have shown that fructose promotes transport of urate via SLC2A9. These observations are of clinical relevance, as fructose ingestion has been strongly associated with development of hyperuricaemia and gout.

We wish to extend our initial observations by examining the influence of SLC2A9 genetic variation on fructose-induced hyperuricaemia. The primary hypothesis is that individuals possessing at least one protective allele at rs11942223 have a lower hyperuricaemic response to a fructose challenge.

This study involves a fructose challenge test for 75 healthy volunteer control participants. The fructose challenge test takes approximately 3 hours and involves ingestion of a fructose/glucose drink and serial measurements of blood urate, creatinine and glucose. Blood will also be obtained for genotyping of SLC2A9 variants and other variants associated with hyperuricaemia
Trial website
Trial related presentations / publications
http://ard.bmj.com/content/72/11/1868.long
http://ard.bmj.com/content/73/1/313.long
Public notes

Contacts
Principal investigator
Name 31944 0
Prof Nicola Dalbeth
Address 31944 0
Room 502-201D
Bone and Joint Research Group
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
85 Park Rd, Grafton, Auckland 1023
Country 31944 0
New Zealand
Phone 31944 0
+64 (0) 9 3737999 x82568
Fax 31944 0
Email 31944 0
n.dalbeth@auckland.ac.nz
Contact person for public queries
Name 15191 0
Prof Nicola Dalbeth
Address 15191 0
Bone and Joint Research Group
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
Park Rd , Grafton, Auckland 1023
Country 15191 0
New Zealand
Phone 15191 0
+64 (0) 9 3737999 x82568
Fax 15191 0
Email 15191 0
n.dalbeth@auckland.ac.nz
Contact person for scientific queries
Name 6119 0
Prof Nicola Dalbeth
Address 6119 0
Bone and Joint Research Group
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
Park Rd , Grafton, Auckland 1023
Country 6119 0
New Zealand
Phone 6119 0
+64 (0) 9 3737999 x82568
Fax 6119 0
Email 6119 0
n.dalbeth@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIBody mass index modulates the relationship of sugar-sweetened beverage intake with serum urate concentrations and gout2015https://doi.org/10.1186/s13075-015-0781-4
Dimensions AIInfluence of the ABCG2 gout risk 141 K allele on urate metabolism during a fructose challenge2014https://doi.org/10.1186/ar4463
N.B. These documents automatically identified may not have been verified by the study sponsor.