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| Sponsor: | Hamilton Health Sciences |
|---|---|
| Information provided by: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT00428571 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Procedure: laparoscopic gastric bypass surgery Procedure: laparoscopic adjustable gastric banding Procedure: intensive medical management (medication, diet, lifestyle) |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Laparoscopic Bariatric Surgery for Treatment of Type 2 Diabetes in Obese Patients With End Organ Damage: A Prospective Randomized Controlled Pilot Study |
| Estimated Enrollment: | 72 |
| Study Start Date: | May 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Obese (BMI 30 # to < 40 kg/m2) patients who have had type 2 diabetes mellitus for more than 5 years, complicated by at least one of the following situations that persist despite adequate management efforts. The complicating situations are:
Despite efforts at optimal glucose control, progressive secondary complications of diabetes as defined by:
Exclusion Criteria:
Any of the following medical conditions that may be associated with DM:
Contacts and Locations| Contact: Karen Barlow | 905-522-1155 ext 35067 | kbarlow@mcmaster.ca |
| Canada, Ontario | |
| St. Joseph's Healthcare | Recruiting |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Sub-Investigator: Arya M Sharma, MD | |
| Sub-Investigator: Charles H Goldsmith, PhD | |
| Sub-Investigator: Monali Misra, MD | |
| Sub-Investigator: Margherita Cadeddu, MD | |
| Sub-Investigator: Gianluca Iacobellis, MD, PhD | |
| Sub-Investigator: Valerie Taylor, MD | |
| Sub-Investigator: Jean-Eric Tarride, PhD | |
| Principal Investigator: Mehran Anvari, MB BS, PhD | |
| Principal Investigator: | Mehran Anvari, MB BS, PhD | Centre for Minimal Access Surgery, McMaster University |
More Information
| Study ID Numbers: | 06-001 |
| Study First Received: | January 26, 2007 |
| Last Updated: | July 10, 2007 |
| ClinicalTrials.gov Identifier: | NCT00428571 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Type 2 Diabetes Bariatric surgery Obesity Laparoscopic gastric bypass Laparoscopic adjustable gastric banding |
|
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |