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临床试验/NCT00288158
NCT00288158已完成2 期

Primary Prevention of Hypertension in Obese Adolescents

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Casual BP

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • 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

研究组 & 干预措施

Allopurinol

Experimental

干预措施: Allopurinol (Drug)

Probenecid

Experimental

干预措施: Probenecid (Drug)

Placebo

Active Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Casual BP

时间窗: 3 months

次要结局

  • 24- hour Ambulatory BP(3 months)
  • Systemic Vascular Resistance (measured by bioimpedance)(3 months)

研究者

研究点 (1)

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