Metabolic Effects of Gastrointestinal Surgery in T2DM

Study Overview
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Brief Summary
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Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes therapy in  80% of patients. Moreover, improvement in insulin sensitivity and glucose homeostasis occurs within days after surgery before significant weight loss is achieved. This observation has led to the notion that bypassing the upper gastrointestinal (GI) tract has specific therapeutic effects on insulin action and glucose metabolism. In fact, both surgical and endoscopic procedures that bypass the upper GI tract are currently being studied in human subjects. Recently, a new surgical technique, duodenal-jejunal bypass surgery (DJBS), has been developed specifically to treat T2DM. Data from preliminary studies have shown that DJBS results in glycemic control in 87% of overweight and obese patients with T2DM.These subjects will undergo metabolic studies at the University Hospital in Sao Paulo before and after their surgical procedure. Washington University investigators will: 1) provide technical support and guidance to the physicians performing the studies in Brazil, 2) process and analyze blood samples obtained from the study at the Washington University Center for Human Nutrition, and 3) be involved in analyzing the data and writing the final manuscripts. The effects of DJBS on the following clinical and metabolic parameters will be evaluated

Official Title
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Metabolic Effects of Duodenal-jejunal Bypass Surgery in Non Morbidly Obese Subjects With Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Procedure: Duodenal jejunal bypass plus sleeve gastrectomy
* Drug: Best medical treatment (Metformin ; gliclazide)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uncontrolled diabetes ( A1c>8%) Less than 10 years of history Not taking insulin Ages between 20 and 65 years old BMI between 26-34 Exclusion Criteria: previous abdominal surgery LADA Using insulin

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Best medical treatment<br>Metformin 2 g/day; gliclazide 30 mg | Drug: Best medical treatment (Metformin ; gliclazide)<br>* Metformin 2 g/day; gliclazide 30 mg<br>|
| Active Comparator: Duodenal jejunal bypass plus sleeve gastrectomy<br>Duodenal jejunal bypass plus sleeve gastrectomy is a metabolic surgical procedure | Procedure: Duodenal jejunal bypass plus sleeve gastrectomy<br>* Metabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb A1a | Primary endpoints- glycemic control | 24 mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic blood pressure control |  | 24 mo | 
| fasting glycemic control |  | 24 months | 
| Lipidic control |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, metabolic surgery, insulin resistance