NCT00428571

Laparoscopic Bariatric Surgery to Treat Type 2 Diabetes in Obese Patients

Laparoscopic Bariatric Surgery for Treatment of Type 2 Diabetes in Obese Patients With End Organ Damage: A Prospective Randomized Controlled Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A large number of research studies on people who were morbidly obese (extremely overweight), and had bariatric surgery (anti-obesity surgery) have shown that patients who were diabetic before surgery often experienced significant improvement in their diabetes following the surgery. For some patients, blood glucose levels returned to the normal range, and they were able to stop taking all of their diabetes medications. For others, blood glucose levels improved, allowing them to reduce their diabetes medications. This research study is being done to determine whether bariatric surgery can safely provide better control of diabetes symptoms in obese diabetics than continuing medical management (anti-diabetic drugs in combination with diet and lifestyle changes). There are several different types of bariatric surgery currently being used to treat morbid obesity. Two of the most common techniques are gastric bypass and adjustable gastric banding. This study will be comparing these two surgical techniques to treatment with a combination of drugs, diet, and lifestyle changes for control of type 2 diabetes.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
PROCEDURE	laparoscopic gastric bypass surgery	Laparoscopic Gastric Bypass Surgery
PROCEDURE	laparoscopic adjustable gastric banding	laparoscopic adjustable gastric banding
PROCEDURE	Intensive Medical Management	lifestyle, diet, medication optimization

Timeline

• Start date: 2007-05-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2007-01-30
• Last updated: 2016-04-14

Locations

1 site across 1 country: Canada