Dietary Interventions Evaluating Transport of Uric Acid Across the Tubules - Full Text View

Sponsored by:	Mount Sinai School of Medicine
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00474396

Purpose

The purpose of the study is to determine whether low fat dairy diet reduces serum uric acid levels.

Condition	Intervention
Healthy	Behavioral: Low fat dairy diet

MedlinePlus related topics: Diets

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Dietary Interventions Evaluating Transport of Uric Acid Across the Tubules

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:

Lowering of serum uric acid levels

Secondary Outcome Measures:

Lowering of the fractional excretion of uric acid and blood pressure

Enrollment:	59
Study Start Date:	April 2005
Study Completion Date:	October 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474396

Sponsors and Collaborators

Mount Sinai School of Medicine

Investigators

Principal Investigator:

Mohammed A Rafey, MD

Mount Sinai School of Medicine

More Information

Publications:

Rafey MA, Lipkowitz MS, Leal-Pinto E, Abramson RG. Uric acid transport. Curr Opin Nephrol Hypertens. 2003 Sep;12(5):511-6. Review.

Choi HK, Atkinson K, Karlson EW, Willett W, Curhan G. Purine-rich foods, dairy and protein intake, and the risk of gout in men. N Engl J Med. 2004 Mar 11;350(11):1093-103.

Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24.

Study ID Numbers:	04-1094
Study First Received:	May 14, 2007
Last Updated:	May 15, 2007
ClinicalTrials.gov Identifier:	NCT00474396 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:

Uric acid
Dairy
Diet

Study placed in the following topic categories:

Uric Acid
Antioxidants
Healthy

Additional relevant MeSH terms:

Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009