The Effect of Bariatric/Metabolic Surgery on GFR

Sponsor
Hanyang University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02406664
Collaborator
(none)
30
1
2
35
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bariatric surgery
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Prospective Cohort Study of the Effect of Bariatric/Metabolic Surgery on Morbid Obesity Patients With Metabolic Syndrome
Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Glomerular filtration rate [before, 6, 12month after surgery]

Secondary Outcome Measures

  1. Change in excessive body weight [before, 6, 12month after surgery]

  2. Systolic function (EF) [Before, 6 and 12month after surgery]

    measured by echocardogram

  3. Diastolic function (E,A,DT,IVRT,E/e') [Before, 6 and 12month after surgery]

    measured by echocardogram

  4. Change of daytime blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure) [Before, 6, and 12month after surgery]

    measured by 24 hours ambulatory blood pressure monitoring

  5. Change of night time blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure) [Before, 6, and 12month after surgery]

    measured by 24 hours ambulatory blood pressure monitoring

  6. Change of 24 hours blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure) [Before, 6, and 12month after surgery]

    measured by 24 hours ambulatory blood pressure monitoring

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hanyang University Hospital Seoul Korea, Republic of 133-792

Sponsors and Collaborators

  • Hanyang University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tae Kyung Ha, Associate Professor, Hanyang University
ClinicalTrials.gov Identifier:
NCT02406664
Other Study ID Numbers:
  • NCT02271568
First Posted:
Apr 2, 2015
Last Update Posted:
Feb 19, 2016
Last Verified:
Feb 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 19, 2016