Metabolic Effects of Gastrointestinal Surgery in T2DM

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Procedure: Duodenal jejunal bypass plus sleeve gastrectomy; Drug: Best medical treatment (Metformin ; gliclazide)

• Registration Number: NCT01771185
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-10
• Status Verified: 2013-01
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-17
• Last Update Submitted: 2013-01-17
• Study First Posted: 2013-01-18
• Last Update Posted: 2013-01-18
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

• previous abdominal surgery
• LADA
• Using insulin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duodenal jejunal bypass plus sleeve gastrectomy	Duodenal jejunal bypass plus sleeve gastrectomy	Duodenal jejunal bypass plus sleeve gastrectomy is a metabolic surgical procedure
Best medical treatment	Best medical treatment (Metformin ; gliclazide)	Metformin 2 g/day; gliclazide 30 mg

Primary Outcome Measures

Name	Time	Method
Hb A1a	24 mo	Primary endpoints- glycemic control

Secondary Outcome Measures

Name	Time	Method
Systolic and diastolic blood pressure control	24 mo
fasting glycemic control	24 months
Lipidic control	24 months