A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2
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|ClinicalTrials.gov Identifier: NCT01197963|
Recruitment Status : Terminated (IRB temporarily halted enrollment)
First Posted : September 9, 2010
Last Update Posted : June 12, 2015
The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes.
The surgical procedures:
- a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying.
- ileal transposition which involves repositioning a 150cm segment of the ileum into the jejunum causing improved glucose homeostasis.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Procedure: Sleeve Gastrectomy and Ileal transposition Dietary Supplement: dietary and medical management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Surgical treatment of one arm of the patient population.
Procedure: Sleeve Gastrectomy and Ileal transposition
Laparoscopic sleeve gastrectomy with ileal transposition
Medically controlled group
Managed by endocrinologists using current medical therapy such as pills, injections and life style medication.
Dietary Supplement: dietary and medical management
dietary and medical routine management patients are currently following with an endocrinologist.
- Serial Postoperative HgA1c levels [ Time Frame: 1 month intervals for 3 months then every 3 months there after ]Effectiveness of the transposition to alleviate hyperglycemia will be measured by following serial post operative HbA1c levels. The change from baseline mearusements will be used to determine the outcome. Type 2 diabetes is considered resolved if there is normalization of fasting glucose(<110 mg/dl) normal HbA1c (<6%) and no need for diabetic medications.
- Serial Postoperative Lipid Profiles levels [ Time Frame: 1 month for the first 3 months then every 3 months there after ]Lipid profiles will be examined at follow up witha goal of total cholesterol <200 mg/dl, low-density lipoprotein (LDL) levels <100 mg/dl, triglyceride levels <150 mg/dl, and high-density lipoprotein (HDL) levels >40 mg/dl. Patients will be fasting for 8 hours and the serum glucose and GLP-1 level will be checked.
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): NCT01197963
|United States, Texas|
|The University of Texas|
|Bellaire, Texas, United States, 77494|
|Principal Investigator:||Brad E Snyder, MD||The University of Texas Health Science Center, Houston|