Primary Prevention of Hypertension in Obese Adolescents
2 other identifiers
interventional
60
1 country
1
Brief Summary
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:
- 1.Test the hypothesis that lowering uric acid will improve endothelial function.
- 2.Test the hypothesis that lowering uric acid will reduce plasma renin activity and serum angiotensin II levels.
- 3.Test the hypothesis that lowering uric acid will reduce markers of inflammation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 obesity
Started Sep 2008
Typical duration for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedSeptember 14, 2017
September 1, 2017
2.3 years
February 6, 2006
September 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Casual BP
3 months
Secondary Outcomes (2)
24- hour Ambulatory BP
3 months
Systemic Vascular Resistance (measured by bioimpedance)
3 months
Study Arms (3)
Allopurinol
EXPERIMENTALProbenecid
EXPERIMENTALPlacebo
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Children's Hospital
Houston, Texas, 77030, United States
Related Publications (2)
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.
PMID: 23006736DERIVEDFravel 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.
PMID: 21849262DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel I Feig, MD, PhD
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 7, 2006
Study Start
September 1, 2008
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
September 14, 2017
Record last verified: 2017-09