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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 19, 2015
CompletedFirst Posted
Study publicly available on registry
April 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 19, 2016
February 1, 2016
1.9 years
March 19, 2015
February 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Glomerular filtration rate
before, 6, 12month after surgery
Secondary Outcomes (6)
Change in excessive body weight
before, 6, 12month after surgery
Systolic function (EF)
Before, 6 and 12month after surgery
Diastolic function (E,A,DT,IVRT,E/e')
Before, 6 and 12month after surgery
Change of daytime blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)
Before, 6, and 12month after surgery
Change of night time blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)
Before, 6, and 12month after surgery
- +1 more secondary outcomes
Study Arms (2)
Obese patients
EXPERIMENTAL15 Obese patients (BMI\>30) having one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension) and morbid obese patients (BMI\>35) accepted for bariatric surgery.
Control patients
NO INTERVENTION15 matched controls receiving Intensive medical therapy
Interventions
Eligibility Criteria
You may qualify if:
- Morbid obesity (BMI\>30) patients with one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension)
- Morbid obese patients (BMI\>35)
You may not qualify if:
- Prior bariatric surgery
- Malignancy (any type)
- End stage renal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang University Hospital
Seoul, 133-792, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tae Kyung Ha, MD, PhD
Hanyang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 19, 2015
First Posted
April 2, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
February 19, 2016
Record last verified: 2016-02