Trial from ANZCTR


Trial ID ACTRN12610001036000
Trial Status: Registered
Date Submitted: 23/11/2010
Date Registered: 24/11/2010
Prospectively registered

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Public title Finding the Genes for Gout: the effect of fructose
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format The influence of genetic variants on fructose-induced hyperuricaemia
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Secondary ID [1] 253146 0
NA
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Trial acronym
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Health condition(s) or problem(s) studied:
Hyperuricaemia 258697 0
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Gout 258707 0
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Condition category: Condition code:
Metabolic and Endocrine Other metabolic disorders
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Descriptions 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.
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Intervention Code:
Not applicable - Observational study 257652 0
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Comparator / control treatment Nil
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Control group Uncontrolled
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Primary Outcome: Change in serum urate concentration following a fructose challenge (blood test) 259702 0
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Timepoint: 30 minutes, 60 minutes, 120 minutes, and 180 minutes after ingestion 259702 0
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Secondary Outcome: Change in fractional excretion of urate to 3 hours following a fructose challenge (blood and urine test) 266421 0
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Timepoint: 30 minutes, 60 minutes, 120 minutes, and 180 minutes after ingestion 266421 0
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Key inclusion criteria Able to provide written informed consent
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Minimum age 18 Years
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Maximum age 85 Years
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Gender Both males and females
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Healthy volunteers? Yes
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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
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Study type Observational
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Patient registry
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Target follow-up duration  
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Purpose Natural history
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Duration Cross-sectional
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Selection Convenience sample
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Timing Prospective
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/08/2011
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Target sample size 75
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Recruitment status Not yet recruiting
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Recruitment outside Australia

Country: New Zealand 3063 0
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State/Province: Auckland 3063 0
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Funding Source: Government body 258119 0
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Name: Health Research Council of New Zealand 258119 0
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Address: PO Box 5541, Wellesley Street, Auckland, 1141, New Zealand 258119 0
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Country: New Zealand 258119 0
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Primary Sponsor Government body
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Name: Health Research Council of New Zealand
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Address: PO Box 5541, Wellesley Street, Auckland, 1141, New Zealand
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Country: New Zealand
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Secondary Sponsor: None 257297 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Multiregion Ethics Committee 260103 0
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Address: PO Box 5013
Wellington
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Country: New Zealand 260103 0
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Approval Date: 27/07/2010 260103 0
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Submitted Date: 260103 0
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HREC: MEC/05/10/130 260103 0
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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
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Trial website
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Principal Investigator
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Contact person for public queries
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Name: Dr Nicola Dalbeth
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Address: Bone and Joint Research Group Department of Medicine Faculty of Medical and Health Sciences University of Auckland Park Rd , Grafton, Auckland 1023
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Country: New Zealand
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Tel: +64 (0) 9 3737999 x82568
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Email: n.dalbeth@auckland.ac.nz
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Contact person for scientific queries
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Name: Dr Nicola Dalbeth
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Address: Bone and Joint Research Group Department of Medicine Faculty of Medical and Health Sciences University of Auckland Park Rd , Grafton, Auckland 1023
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Country: New Zealand
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Tel: +64 (0) 9 3737999 x82568
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Email: n.dalbeth@auckland.ac.nz
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Addition Cancer fields
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