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IRB temporarily halted enrollment
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The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes.
The surgical procedures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical treatment | Other | Surgical treatment of one arm of the patient population. |
|
| Medically controlled group | Other | Managed by endocrinologists using current medical therapy such as pills, injections and life style medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeve Gastrectomy and Ileal transposition | Procedure | Laparoscopic sleeve gastrectomy with ileal transposition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serial Postoperative HgA1c levels | 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. | 1 month intervals for 3 months then every 3 months there after |
| Measure | Description | Time Frame |
|---|---|---|
| Serial Postoperative Lipid Profiles levels | 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. | 1 month for the first 3 months then every 3 months there after |
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Inclusion Criteria:
Exclusion Criteria:
Type I diabetes/juvenile onset
C-Peptid levels below 1.0 ng/ml
Previous major upper abdominal surgery
--Pregnant or plans to become pregnant with in the next 12 months
Current Malignancy
Severe pulmonary, cardia, or renal disease
Eating disorders such as bulimia or binge-eating
Severe mental health disorders such as schizophrenia and bipolar disorder
Obesity due to other metabolic disorders
taking appetite suppressants
currently abusing illicit drugs,alcohol or using tobacco products
Unable to provide informed consent
Unwillingness or unable to comply with study procedures
any condition that deems them unsuitable for the study in the opinion of the investigators
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| Name | Affiliation | Role |
|---|---|---|
| Brad E Snyder, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas | Bellaire | Texas | 77494 | United States |
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| dietary and medical management | Dietary Supplement | dietary and medical routine management patients are currently following with an endocrinologist. |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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