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

• Conditions: Metabolic Syndrome; Obesity
• Interventions: Procedure: Bariatric surgery; Other: Intensive medical therapy

• Registration Number: NCT02271568
• Lead Sponsor: Hanyang University

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.

Study Timeline

• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-19
• Study First Posted: 2014-10-22
• Study Start: 2015-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese patients	Bariatric surgery	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.
Control patients	Intensive medical therapy	15 matched controls receiving Intensive medical therapy

Primary Outcome Measures

Name	Time	Method
Change in Glomerular filtration rate	prior to surgery - 1, 3, 6, 12month after surgery

Secondary Outcome Measures

Name	Time	Method
24 hours ambulatory blood pressure	prior to surgery - 1, 3, 6, 12month after surgery
Change in excessive body weight	1, 3, 6, 12month after surgery
Echocardiographic parameter (Systolic and Diastolic parameters, baPWV and LV function)	Before and 12month after surgery

Trial Locations

Locations (1)

Hanyang University Seoul Hospital; 🇰🇷 Seongdong-gu, Seoul, Korea, Republic of