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临床试验/NCT01332526
NCT01332526Unknown不适用

The Oral Fructose Load Test and Inflammation, Lipid Metabolism, Blood Pressure and Organ Damage in Patients With Obesity, Chronic Kidney Disease With Comparison With Healthy Controls.

Collegium Medicum w Bydgoszczy0 个研究点目标入组 70 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70

研究概览

简要总结

Fructose intake from added sugars has increased dramatically over the last century and has recently been implicated as potential contributor to metabolic syndrome, obesity, hypertension, inflammation and kidney disease. Fructose differs from the other sugars because, uric acid is generated during its metabolism. Serum uric acid levels have been found to correlate with the intake of fructose and added sugars. In turn, an elevated serum uric acid has also been shown to be associated with increased risk for cardiovascular and metabolic diseases. On the other hand complexity of fructose metabolism in each individuals results of the various magnitude of hyperuricemia induced by fructose intake. The magnitude of uric acid production in each patient may reflect individual predisposition to endogenous urate production in a face of relatively normal fasting uric acid concentration. Therefore the oral fructose tolerance test might reveal an occult purine disturbances which plays casual role in either metabolic disturbances or organ damage.

The aim of this study is to see whether is a relationship between fructose induced hyperuricemia and metabolic disturbances , inflammatory state and organ damage in obese and various stages CKD patients.

详细描述

The study will be performed in two experimental groups. Proposed study groups Study I Patients with BMI> 30 and metabolic syndrome. Patient with BMI> 30 without metabolic syndrome. Normal healthy controls. Study II Patients with CKD stage III and uric acid < 7 mg/dl Patients with CKD stage III and uric acid > 7 mg/dl Patient with asymptomatic hyperuricemia and eGFR > 90 ml/min/1.73 m2, , uric acid > 7 mg/dl Hemodialysis patients

Characteristics of the particular patients group- including criteria:

10- 15 participants in each subset of each group age 18-65 y. Gender: females and males in equal proportion. Group I Patients with BMI> 30 and metabolic syndrome ( ATP III). Patient with BMI> 30 without metabolic syndrome. Normal healthy control- healthy persons( without renal disease, cardiovascular diseases, diabetes mellitus, BMI < 25;normotensives ).

Group II Patients with CKD stage III (GFR 30-59 ml/min/1,73 m2) and uric acid < 7 mg/dl.

  • without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressive agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg) Patients with CKD stage III(GFR 30-59 ml/min/1,73 m2) and uric acid > 7 mg/dl
  • without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressive agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Group I Patients with BMI> 30 and metabolic syndrome ( ATP III). Patient with BMI> 30 without metabolic syndrome. Normal healthy control- healthy persons( without renal disease, cardiovascular diseases, diabetes mellitus, BMI < 25;normotensives ).
  • Group II Patients with CKD stage III (GFR 30-59 ml/min/1,73 m2) and uric acid < 7 mg/dl.
  • without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressives agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg) Patients with CKD stage III(GFR 30-59 ml/min/1,73 m2) and uric acid > 7 mg/dl
  • without diabetes mellitus proteinuria < 3,5 g/24 h without immunosuppressive agents, ACEi, ARB, allopurinol treatment well controlled hypertension ( < 140/90 mmHg)
  • Patient with asymptomatic hyperuricemia, uric acid > 7 mg/dl with normal renal function Hemodialysis patients.
  • CKD: nondiabetic nephropathy
  • duration hemodialysis 3-48 months
  • Hb-11-13 g/dl
  • well controlled hypertension ( < 140/90 mmHg)
  • without ACEi, ARB, allopurinol treatment
  • residual diuresis will be estimated for last 48 hours-between mid and next dialysis

排除标准

  • immunosuppressive agents, ACEi, ARB, allopurinol treatment
  • diabetes mellitus
  • not well controlled hypertension ( > 140/90 mmHg)
  • proteinuria > 3,5 g/24 h

研究者

发起方
Collegium Medicum w Bydgoszczy
申办方类型
Other

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