The Effect of Bariatric/Metabolic Surgery on GFR

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

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Procedure: Bariatric surgery

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 133-792
    • Recruiting
    • Hanyang University Hospital
    • Contact: Tae Kyung Ha, MD, PhD; Phone Number: 82-2-2290-8444; Email: missurgeon@hanyang.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obese patients; 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.	Procedure: Bariatric surgery; Laparoscopic or Robot R-Y gastric bypass
No Intervention: Control patients; 15 matched controls receiving Intensive medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Glomerular filtration rate	before, 6, 12month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in excessive body weight		before, 6, 12month after surgery
Systolic function (EF)	measured by echocardogram	Before, 6 and 12month after surgery
Diastolic function (E,A,DT,IVRT,E/e')	measured by echocardogram	Before, 6 and 12month after surgery
Change of daytime blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)	measured by 24 hours ambulatory blood pressure monitoring	Before, 6, and 12month after surgery
Change of night time blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)	measured by 24 hours ambulatory blood pressure monitoring	Before, 6, and 12month after surgery
Change of 24 hours blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)	measured by 24 hours ambulatory blood pressure monitoring	Before, 6, and 12month after surgery

Collaborators and Investigators

• Sponsor: Hanyang University
• Investigators: Principal Investigator: Tae Kyung Ha, MD, PhD, Hanyang University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 19, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: NCT02271568