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

Study Overview
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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.

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

Conditions
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Obesity, Metabolic Syndrome

Intervention / Treatment
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* Procedure: Bariatric surgery
* Other: Intensive medical therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese patients<br>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<br>* Laparoscopic or Robot R-Y gastric bypass<br>|
| Control patients<br>15 matched controls receiving Intensive medical therapy | Other: Intensive medical therapy<br>* intensive medical therapy according to published guidelines by ADA and EASD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glomerular filtration rate |  | prior to surgery - 1, 3, 6, 12month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in excessive body weight |  | 1, 3, 6, 12month after surgery | 
| Echocardiographic parameter (Systolic and Diastolic parameters, baPWV and LV function) |  | Before and 12month after surgery | 
| 24 hours ambulatory blood pressure |  | prior to surgery - 1, 3, 6, 12month after surgery |