A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Procedure: Sleeve Gastrectomy and Ileal transposition
* Dietary Supplement: dietary and medical management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age- 21-55 years. Body Mass Index between 25-35 kf/m2. currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years. Documented HbA1c>7.5% for at least 3 months. Stable weight for 3 months (+/-) Evidence of stable medical treatment for diabetes over the past 12 months. Able to provide informed consent -Female subject agrees to participate in accepted birth control methods - 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Surgical treatment<br>Surgical treatment of one arm of the patient population. | Procedure: Sleeve Gastrectomy and Ileal transposition<br>* Laparoscopic sleeve gastrectomy with ileal transposition<br>|
| Other: Medically controlled group<br>Managed by endocrinologists using current medical therapy such as pills, injections and life style medication. | Dietary Supplement: dietary and medical management<br>* dietary and medical routine management patients are currently following with an endocrinologist.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes mellitus