Clinical trial NCT02271568: Prospective Cohort Study of the Effect of Bariatric/Metabolic Surgery on Morbid Obesity Patients With Metabolic Syndrome
Official title: Change in Glomerular Filtration Rate and 24 Hours Ambulatory Blood Pressure After Gastric Bypass Surgery Versus Conventional Weight Loss in Morbid Obesity.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Metabolic Syndrome
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. 15 matched controls.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Glomerular filtration rate
timeFrame: prior to surgery - 1, 3, 6, 12month after surgery
Secondary outcomes:
measure: Change in excessive body weight
timeFrame: 1, 3, 6, 12month after surgery
measure: Echocardiographic parameter (Systolic and Diastolic parameters, baPWV and LV function)
timeFrame: Before and 12month after surgery
measure: 24 hours ambulatory blood pressure
timeFrame: prior to surgery - 1, 3, 6, 12month after surgery
Other outcomes:
Locations:
city: Seongdong-gu
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
state: Seoul
Study officials:
affiliation: Hanyang University Seoul Hospital
name: Tae Kyung Ha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: