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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02271568
Enrollment
30
Registered
2014-10-22
Start date
2015-03-31
Completion date
2017-12-31
Last updated
2016-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Obesity

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.

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.

Interventions

PROCEDUREBariatric surgery

Laparoscopic or Robot R-Y gastric bypass

intensive medical therapy according to published guidelines by ADA and EASD

Sponsors

Hanyang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Change in Glomerular filtration rateprior to surgery - 1, 3, 6, 12month after surgery

Secondary

MeasureTime frame
Change in excessive body weight1, 3, 6, 12month after surgery
Echocardiographic parameter (Systolic and Diastolic parameters, baPWV and LV function)Before and 12month after surgery
24 hours ambulatory blood pressureprior to surgery - 1, 3, 6, 12month after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026