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Clinical Trials/NCT02406664
NCT02406664
Unknown
Not Applicable

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

Hanyang University1 site in 1 country30 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
Hanyang University
Enrollment
30
Locations
1
Primary Endpoint
Change in Glomerular filtration rate
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
December 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tae Kyung Ha

Associate Professor

Hanyang University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in Glomerular filtration rate

Time Frame: before, 6, 12month after surgery

Secondary Outcomes

  • 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)

Study Sites (1)

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