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Primary Prevention of Hypertension in Obese Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00288158
First Posted: February 7, 2006
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baylor University
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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:

  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

Condition Intervention Phase
Obesity Pre-Hypertension Hyperuricemia Drug: Allopurinol Drug: Probenecid Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Casual BP [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • 24- hour Ambulatory BP [ Time Frame: 3 months ]
  • Systemic Vascular Resistance (measured by bioimpedance) [ Time Frame: 3 months ]

Enrollment: 60
Actual Study Start Date: September 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allopurinol Drug: Allopurinol
Experimental: Probenecid Drug: Probenecid
Active Comparator: Placebo Drug: Placebo

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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): NCT00288158


Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor University
Investigators
Principal Investigator: Daniel I Feig, MD, PhD Baylor College of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00288158     History of Changes
Other Study ID Numbers: DK71223 (completed)
R21DK071223 ( U.S. NIH Grant/Contract )
First Submitted: February 6, 2006
First Posted: February 7, 2006
Last Update Posted: September 14, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Hyperuricemia
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Allopurinol
Probenecid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs
Uricosuric Agents
Renal Agents