The Surgical Treatment of Type 2 Diabetes Mellitus in Non-Morbidly Obese Patients: A Community Hospital Study
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|ClinicalTrials.gov Identifier: NCT01323114|
Recruitment Status : Unknown
Verified March 2011 by McKenzie Health System.
Recruitment status was: Recruiting
First Posted : March 25, 2011
Last Update Posted : April 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Procedure: Laparoscopic duodenal exclusion Other: Conventional Medical Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Surgical Treatment of Type 2 Diabetes Mellitus in Non-Morbidly Obese Patients: A Community Hospital Study|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||May 2014|
Active Comparator: Medical Control Group
Control group of patients who will receive conventional medical treatment for type 2 diabetes, along with regular dietary and diabetic education, under the monitoring of the study endocrinologist.
Other: Conventional Medical Treatment
Standard of care medical treatment for type 2 diabetes to include medications and dietary management under the monitoring of the study endocrinologist.
Other Name: control arm
Experimental: Surgical Treatment Group
Experimental group in which patients will undergo the laparoscopic duodenal bypass procedure along with regular dietary and diabetic education, under the monitoring of the study endocrinologist.
Procedure: Laparoscopic duodenal exclusion
Laparoscopically-performed Roux-en Y intestinal bypass of the duodenum and proximal jejunum; stomach remains normal size and proximal division performed just distal to pylorus.
- Hemoglobin A1C [ Time Frame: One year ]The primary outcome is the difference in hemoglobin A1C between the surgical treatment arm and the conventional medical treatment arm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323114
|Contact: Marcus K Free, M.D.||firstname.lastname@example.org|
|United States, Michigan|
|McKenzie Health System||Recruiting|
|Sandusky, Michigan, United States, 48471|
|Contact: Marcus K Free, M.D. 810-648-9707 email@example.com|
|Contact: Steve Barnett, M.S. 810-648-3770|
|Principal Investigator:||Marcus K. Free, M.D.||McKenzie Health System|
|Study Director:||Steve Barnett, M.S.||McKenzie Health System|