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Trial record 2 of 10 for:    9099655 [PUBMED-IDS]
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Dietary Interventions Evaluating Transport of Uric Acid Across the Tubules (dietUAT)

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ClinicalTrials.gov Identifier: NCT00474396
Recruitment Status : Completed
First Posted : May 16, 2007
Last Update Posted : May 16, 2007
Sponsor:
Information provided by:
Icahn School of Medicine at Mount Sinai

Study Description
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Brief Summary:
The purpose of the study is to determine whether low fat dairy diet reduces serum uric acid levels.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Low fat dairy diet Not Applicable

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 (G/A 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Basic Science
Official Title: Dietary Interventions Evaluating Transport of Uric Acid Across the Tubules
Study Start Date : April 2005
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Uric Acid

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Lowering of serum uric acid levels

Secondary Outcome Measures :
  1. Lowering of the fractional excretion of uric acid and blood pressure

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Healthy adult volunteers

    • Coronary artery disease
    • Glucose intolerance or Diabetes(a fasting blood sugar of less than 100 mg/dl as per the American Diabetes Association guidelines)
    • CHF
    • Gout
    • Lactose intolerance
    • Milk allergy
    • Women who are pregnant or lactating
    • Subjects who are on any medications except birth control pills
    • Subjects who drink more than 3 servings of beer or liquor per week.
    • Normal blood pressure ( less than 120 mmHg systolic and 80 mmHg diastolic)
    • Normal serum UA levels
    • Normal renal funcion (calculated GFR >90ml/min)

Exclusion Criteria:

  • • Coronary artery disease

    • Glucose intolerance or Diabetes(a fasting blood sugar of less than 100 mg/dl as per the American Diabetes Association guidelines)
    • CHF
    • Gout
    • Lactose intolerance
    • Milk allergy
    • Women who are pregnant or lactating
    • Subjects who are on any medications except birth control pills
    • Subjects who drink more than 3 servings of beer or liquor per week
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474396


Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Mohammed A Rafey, MD Icahn School of Medicine at Mount Sinai
More Information
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Publications:

ClinicalTrials.gov Identifier: NCT00474396     History of Changes
Other Study ID Numbers: 04-1094
First Posted: May 16, 2007    Key Record Dates
Last Update Posted: May 16, 2007
Last Verified: May 2007

Keywords provided by Icahn School of Medicine at Mount Sinai:
Uric acid
Dairy
Diet

Additional relevant MeSH terms:
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs