Clinical trial NCT02406664: The Effect of Bariatric/Metabolic Surgery on GFR
Official title: Prospective Cohort Study of the Effect of Bariatric/Metabolic Surgery on Morbid Obesity Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Change in Glomerular filtration rate
timeFrame: before, 6, 12month after surgery
Secondary outcomes:
measure: Change in excessive body weight
timeFrame: before, 6, 12month after surgery
measure: Systolic function (EF)
timeFrame: Before, 6 and 12month after surgery
measure: Diastolic function (E,A,DT,IVRT,E/e')
timeFrame: Before, 6 and 12month after surgery
measure: Change of daytime blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)
timeFrame: Before, 6, and 12month after surgery
measure: Change of night time blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)
timeFrame: Before, 6, and 12month after surgery
measure: Change of 24 hours blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)
timeFrame: Before, 6, and 12month after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
Study officials:
affiliation: Hanyang University
name: Tae Kyung Ha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: