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

NCT02271568 | Unknown DMC

• 1 other identifier: HYUH 2013-07-024-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 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.

Conditions

Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Glomerular filtration rate

  prior to surgery - 1, 3, 6, 12month after surgery

Secondary Outcomes (3)

• 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

Study Arms (2)

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

Control patients

15 matched controls receiving Intensive medical therapy

Other: Intensive medical therapy

Interventions

Bariatric surgery PROCEDURE

Laparoscopic or Robot R-Y gastric bypass

Obese patients

Intensive medical therapy OTHER

intensive medical therapy according to published guidelines by ADA and EASD

Control patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

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

Sponsors & Collaborators

• Hanyang University: lead

Study Sites (1)

Hanyang University Seoul Hospital

Seongdong-gu, Seoul, 133-792, South Korea

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Tae Kyung Ha, MD, PhD

  Hanyang University Seoul Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 22, 2014
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

KR (1)