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Type 2 diabetes mellitus is a chronic disease with severe long-term health consequences. In
patients with type 2 diabetes mellitus who are also morbidly obese, an abundance of clinical
evidence exists showing that significant clinical improvement in their diabetes occurs
following certain types of bariatric, or weight loss, surgical procedures. There is
additional data showing that bariatric surgical procedures that bypass the beginning of the
small intestine, such as the Roux-en Y gastric bypass, can markedly improve type 2 diabetes
even before significant weight loss has occurred. This early effect on type 2 diabetes
prior to weight loss suggests that bypassing the beginning of the small intestine in
patients who are not morbidly obese may also treat type 2 diabetes. There have been small
studies outside the United States that support the concept of treating type 2 diabetes with
a surgical procedure that bypasses the beginning of the small intestine without causing
significant weight loss; however, data is limited in the United States and a call for
comparative studies has been made internationally. The investigators propose to compare, in
patients who are not morbidly obese, conventional medical treatment of type 2 diabetes to
surgical treatment of type 2 diabetes using a bypass procedure that does not cause
significant weight loss, the laparoscopic duodenal exclusion.

Clinical Trial Conditions: Type 2 Diabetes Mellitus

Treatments in this Clinical Trial : Laparoscopic duodenal exclusion, Conventional Medical Treatment

Eligible Clinical Trial Participant Age : Between 20 years to 65 years

Can Healthy Volunteers Participate: No

Clinical Trial Lead Sponsor: McKenzie Health System

Detailed Clinical Trial Description: Type 2 diabetes mellitus is a chronic disease with severe long-term health consequences. In
patients with type 2 diabetes mellitus who are also morbidly obese, an abundance of clinical
evidence exists showing that significant clinical improvement in their diabetes occurs
following certain types of bariatric, or weight loss, surgical procedures. There is
additional data showing that bariatric surgical procedures that bypass the beginning of the
small intestine, such as the Roux-en Y gastric bypass, can markedly improve type 2 diabetes
even before significant weight loss has occurred. This early effect on type 2 diabetes
prior to weight loss suggests that bypassing the beginning of the small intestine in
patients who are not morbidly obese may also treat type 2 diabetes. There have been small
studies outside the United States that support the concept of treating type 2 diabetes with
a surgical procedure that bypasses the beginning of the small intestine without causing
significant weight loss; however, data is limited in the United States and a call for
comparative studies has been made internationally. The investigators propose to compare, in
patients who are not morbidly obese, conventional medical treatment of type 2 diabetes to
surgical treatment of type 2 diabetes using a bypass procedure that does not cause
significant weight loss, the laparoscopic duodenal exclusion.

The clinical trial information was obtained from http://clinicaltrials.gov/ct2/show/NCT01323114

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