- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00288158
Primary Prevention of Hypertension in Obese Adolescents
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:
- Test the hypothesis that lowering uric acid will improve endothelial function.
- Test the hypothesis that lowering uric acid will reduce plasma renin activity and serum angiotensin II levels.
- Test the hypothesis that lowering uric acid will reduce markers of inflammation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Texas Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Placebo
|
|
Experimental: Allopurinol
|
|
Experimental: Probenecid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Casual BP
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24- hour Ambulatory BP
Time Frame: 3 months
|
3 months
|
Systemic Vascular Resistance (measured by bioimpedance)
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Daniel I Feig, MD, PhD, Baylor College of Medicine
Publications and helpful links
General Publications
- Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.
- Soletsky B, Feig DI. Uric acid reduction rectifies prehypertension in obese adolescents. Hypertension. 2012 Nov;60(5):1148-56. doi: 10.1161/HYPERTENSIONAHA.112.196980. Epub 2012 Sep 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Prehypertension
- Hyperuricemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites
- Protective Agents
- Antioxidants
- Free Radical Scavengers
- Gout Suppressants
- Renal Agents
- Uricosuric Agents
- Allopurinol
- Probenecid
Other Study ID Numbers
- DK71223 (completed)
- R21DK071223 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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