The Effect of Bariatric/Metabolic Surgery on GFR

NCT ID: NCT02406664

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

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

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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Metabolic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

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.

Group Type EXPERIMENTAL

Bariatric surgery

Intervention Type PROCEDURE

Laparoscopic or Robot R-Y gastric bypass

Control patients

15 matched controls receiving Intensive medical therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bariatric surgery

Laparoscopic or Robot R-Y gastric bypass

Intervention Type PROCEDURE

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

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae Kyung Ha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

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Hanyang University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Tae Kyung Ha, MD,PhD

Role: CONTACT

82-2-2290-8444

Facility Contacts

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Tae Kyung Ha, MD, PhD

Role: primary

82-2-2290-8444

Other Identifiers

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NCT02271568

Identifier Type: -

Identifier Source: org_study_id

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