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

NCT ID: NCT02271568

Last Updated: 2016-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Obesity Metabolic Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bariatric surgery

Intervention Type PROCEDURE

Laparoscopic or Robot R-Y gastric bypass

Control patients

15 matched controls receiving Intensive medical therapy

Intensive medical therapy

Intervention Type OTHER

intensive medical therapy according to published guidelines by ADA and EASD

Interventions

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Bariatric surgery

Laparoscopic or Robot R-Y gastric bypass

Intervention Type PROCEDURE

Intensive medical therapy

intensive medical therapy according to published guidelines by ADA and EASD

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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Tae Kyung Ha

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae Kyung Ha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University Seoul Hospital

Locations

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Hanyang University Seoul Hospital

Seongdong-gu, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HYUH 2013-07-024-001

Identifier Type: -

Identifier Source: org_study_id

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