The Surgical Treatment of Type 2 Diabetes Mellitus in Non-Morbidly Obese Patients: A Community Hospital Study
Status unconfirmed · Not applicable
Conditions studied: Type 2 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT01323114
- Run by
- McKenzie Health System
- People needed
- 66
- Starts
- 2011-04-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2011-04-13
Who can join
Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosis of type 2 diabetes mellitus
- fasting blood glucose > 126 mg/dl
- on hypoglycemic medications for the treatment of type 2 diabetes
- inadequate control of diabetes with glycosylated hemoglobin A1c > 7.5
- body mass index between 20 and 35
- C-peptide level 1.0 mg/dl or higher
- ability to understand the proposed surgical treatment and its mechanism
- ability to understand the risks and benefits of the proposed surgery
- ability to commit to the study requirements for followup and education
- ability to give properly informed consent for participation
You may not qualify if…
- body mass index 35 or higher, or less than 20
- previous diagnosis of type 1 diabetes mellitus or mixed diabetes
- pregnancy, within one year postpartum, or currently breastfeeding
- recent (within 1 year) gastric or duodenal ulcer
- use of immunosuppressive medications or known immunosuppressive disorder
- previous gastric, duodenal, or small intestinal surgery
- inflammatory bowel disease
- treatment with anticoagulant or antiplatelet medication other than aspirin 81 mg/day
- end-stage renal disease or on dialysis
- any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to participate in the study
Where it is running
- McKenzie Health System — Sandusky, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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