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.

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Metabolic Syndrome
• Intervention / Treatment: Procedure: Bariatric surgery; Other: Intensive medical therapy

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Seongdong-gu, Seoul, Korea, Republic of, 133-792
      • Hanyang University Seoul Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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
Control patients; 15 matched controls receiving Intensive medical therapy	Other: Intensive medical therapy; intensive medical therapy according to published guidelines by ADA and EASD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hanyang University
• Investigators: Principal Investigator: Tae Kyung Ha, MD, PhD, Hanyang University Seoul Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: October 19, 2014
• First Posted (Estimate): October 22, 2014

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Obesity; Metabolic Syndrome; Obesity, Morbid
• Other Study ID Numbers: HYUH 2013-07-024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED