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Primary Prevention of Hypertension in Obese Adolescents

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00288158
First received: February 6, 2006
Last updated: April 25, 2011
Last verified: April 2011
History of Changes
  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 vs. Probenecid vs. Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Systemic Vascular Resistance (measured by bioimpedance)
  • Brachial Artery Reactivity
  • Serum Angiotensin 2
  • Serum MCP-1

Secondary Outcome Measures:
  • Ambulatory BP
  • Casual BP
  • thromboxane B2
  • leptin adiponectin
  • IL-6
  • endothelin
  • PAI-1

Estimated Enrollment: 128
Study Start Date: February 2006
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

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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)
Investigators
Principal Investigator: Daniel I Feig, MD, PhD Baylor College of Medicine
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00288158     History of Changes
Other Study ID Numbers: DK71223 (completed)
Study First Received: February 6, 2006
Last Updated: April 25, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hypertension
Obesity
Hyperuricemia
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes
Allopurinol
Probenecid
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs
Uricosuric Agents
Renal Agents

ClinicalTrials.gov processed this record on May 16, 2013