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

Obesity Clinical Trial

Official title:

Change in Glomerular Filtration Rate and 24 Hours Ambulatory Blood Pressure After Gastric Bypass Surgery Versus Conventional Weight Loss in Morbid Obesity.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02271568
• Other study ID #: HYUH 2013-07-024-001
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 16, 2014
• Last updated: February 18, 2016
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Bariatric surgery
Laparoscopic or Robot R-Y gastric bypass

Other:
• Intensive medical therapy
intensive medical therapy according to published guidelines by ADA and EASD

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Seoul Hospital	Seongdong-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glomerular filtration rate		prior to surgery - 1, 3, 6, 12month after surgery	No
Secondary	Change in excessive body weight		1, 3, 6, 12month after surgery	No
Secondary	Echocardiographic parameter (Systolic and Diastolic parameters, baPWV and LV function)		Before and 12month after surgery	No
Secondary	24 hours ambulatory blood pressure		prior to surgery - 1, 3, 6, 12month after surgery	No