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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00288158 |
Purpose
The purpose of this study is to examine the consequences of lowering serum uric acid in pre-hypertensive, obese adolescents pathways involved with how uric acid mediated hypertension and renal disease. The specific aims are:
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Pre-Hypertension Hyperuricemia |
Drug: Allopurinol vs. Probenecid vs. Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Estimated Enrollment: | 128 |
| Study Start Date: | February 2006 |
The trial will be a double blinded, placebo control trial of two uric acid lowering agents. The endpoints for this trial will be, endothelial function, systemic vascular resistance, plasma renin activity, MCP-1 and CRP. Upon recruitment and informed consent, children will undergo initial screening. This will include medical history, family history, dietary history, review of systems (questionnaire used and validated in pediatric hypertension clinic) and pediatric quality of life questionnaire. They will have a physical exam, casual and ambulatory blood pressure monitoring (see below) and screening laboratory analysis that will include CBC, electrolytes, BUN, Cr, Uric acid, AST, ALT and urinary micro-albumin to creatinine ratio. Children with serum uric acid less than 5.0mg per dl will be enrolled as controls and only have baseline studies at Screening and Visit 1. Children with serum uric acid equal to or greater than 5.0mg per dl will be randomized (in a one to one to one ratio) to receive placebo, allopurinol or probenecid.
Study drug (or placebo) will be administered for 2 months. During the first week, subjects will take one tablet (placebo, 150mg allopurinol or 250mg probenecid) twice daily. At the end of one week subjects will be instructed to increase to 2 tablets (placebo, 300mg allopurinol or 500mg probenecid) twice daily. Data collection will occur during screening, after one and two months on the study drug and one month after completion of the study drug.
Eligibility| Ages Eligible for Study: | 11 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Children between the ages of 11 and 18
body mass index greater than the 95th percentile for age
Blood pressure between 75th and 95th percentile for age, gender and height percentile
Exclusion Criteria:
hypertension at the time of screening
allergy to one of the study medications
liver function abnormality (AST or ALT greater than twice the upper limit of
normal for the laboratory)
history of renal stones
renal insufficiency (Schwartz formula calculated GFR less than 70ml per min per 1.73m2 BSA)
positive urine pregnancy test
diabetes
organ transplant recipient
currently treated with an angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), diuretic, other medications known to alter serum uric acid level
lack of ability to comply with the study protocol
Contacts and Locations More Information
| Study ID Numbers: | DK71223 |
| Study First Received: | February 6, 2006 |
| Last Updated: | July 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00288158 History of Changes |
| Health Authority: | United States: Federal Government |
|
Antimetabolites Obesity Allopurinol Antioxidants Vascular Diseases Hyperuricemia Overweight |
Body Weight Signs and Symptoms Probenecid Nutrition Disorders Overnutrition Antirheumatic Agents Hypertension |
|
Antimetabolites Obesity Allopurinol Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vascular Diseases Hyperuricemia Enzyme Inhibitors Overweight Protective Agents Gout Suppressants |
Pharmacologic Actions Body Weight Signs and Symptoms Pathologic Processes Therapeutic Uses Free Radical Scavengers Nutrition Disorders Cardiovascular Diseases Overnutrition Antirheumatic Agents Hypertension |
