Viewing Study NCT00474396



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Study NCT ID: NCT00474396
Status: COMPLETED
Last Update Posted: 2007-05-16
First Post: 2007-05-14

Brief Title: Dietary Interventions Evaluating Transport of Uric Acid Across the Tubules
Sponsor: Icahn School of Medicine at Mount Sinai
Organization: Icahn School of Medicine at Mount Sinai

Study Overview

Official Title: Dietary Interventions Evaluating Transport of Uric Acid Across the Tubules
Status: COMPLETED
Status Verified Date: 2007-05
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: dietUAT
Brief Summary: The purpose of the study is to determine whether low fat dairy diet reduces serum uric acid levels
Detailed Description: Uric acid plays a role not only in the pathogenesis of gout but is also a predictor of cardiovascular disease hypertension and renal disease in man We have identified the human urate ion channel transporter hUAT located in the proximal convoluted tubule of the kidney that is involved in both the secretion and reabsorption of urate across the tubule This channel has a unique lectin binding site that in in-vitro studies has been found to be modulated by glucose galactose and lactose We have also identified a mutation GA polymorphism in our laboratory that in in-vitro studies has demonstrated diminished hUAT channel activity Cross-sectional studies have earlier shown that uric acid levels vary with serum glucose levels Studies have also reported that a low-fat dairy diet reduces the incidence of gout while others have shown that this diet reduces blood pressure significantly when compared with a non-dairy diet We hypothesize that the effect of blood glucose levels in lowering uric acid levels is through the regulation of hUAT channel activity We also hypothesize that a low-fat dairy diet reduces serum uric acid levels through hUAT regulation leading to a decrease in the incidence of gout and a reduction in blood pressure levels In our proposed randomized controlled cross-over trial in healthy adult volunteers we aim to study the effect of a low-fat dairy diet and a non-dairy diet on serum uric acid levels the renal fractional excretion of uric acid and blood pressure We will also study the effect of an acute intravenous infusion of glucose on these parameters DNA analysis for hUAT mutations of study subjects will be done to assess if there is a blunted response of hUAT activity in subjects with the polymorphism as compared to normal individuals

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