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临床试验/NCT02406664
NCT02406664Unknown不适用

Prospective Cohort Study of the Effect of Bariatric/Metabolic Surgery on Morbid Obesity Patients With Metabolic Syndrome

Hanyang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Change in Glomerular filtration rate

研究概览

简要总结

The purpose of this study is to determine the change in kidney function and blood pressure after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment.

详细描述

Metabolic syndrome is strongly associated with obesity and the patients with this syndrome are at increased risk for cardiovascular disease. Obesity constitutes a strong risk factor for the development of chronic kidney disease. Among diabetics, obesity is known to amplify the risk for kidney disease. Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome. In addition, many observational studies have demonstrated significant reduction in proteinuria after bariatric surgery.

However, the changes in the component of cardiovascular problem among metabolic syndrome and changes in renal filtration function or progression to end stage kidney disease in morbidly obese patients after weight loss surgery have not been extensively studied. Therefore, our study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Morbid obesity (BMI>30) patients with one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension)
  • •Morbid obese patients (BMI>35)

排除标准

  • •Prior bariatric surgery
  • •Malignancy (any type)
  • •End stage renal disease

研究组 & 干预措施

Obese patients

Experimental

15 Obese patients (BMI>30) having one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension) and morbid obese patients (BMI>35) accepted for bariatric surgery.

干预措施: Bariatric surgery (Procedure)

Control patients

No Intervention

15 matched controls receiving Intensive medical therapy

结局指标

主要结局

Change in Glomerular filtration rate

时间窗: before, 6, 12month after surgery

次要结局

  • Change in excessive body weight(before, 6, 12month after surgery)
  • Systolic function (EF)(Before, 6 and 12month after surgery)
  • Diastolic function (E,A,DT,IVRT,E/e')(Before, 6 and 12month after surgery)
  • Change of daytime blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)(Before, 6, and 12month after surgery)
  • Change of night time blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)(Before, 6, and 12month after surgery)
  • Change of 24 hours blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)(Before, 6, and 12month after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tae Kyung Ha

Associate Professor

Hanyang University

研究点 (1)

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