The Curative Effect of the Length of the Jejunum Exclusion in Grstric Bypass Surgery for Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to investigate the curative effect of the length of the jejunum exclusion in gastric surgry for T2DM and metabolic syndrome,and to draft Scientific and reasonable operation parameters.

Detailed Description
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Currently, there is a growing evidence supports the efficacy of Roux-en-Y gastric bypass for the treatment of Type 2 diabetes mellitus. However,there still have a great controversy about the operation parameters. With randomized controlled trial, Patients of BMI>21kg/m2 with type 2 diabetes were randomly divided into two groups: short biliarypancreatic limb:50cm;long biliarypancreatic limb :100cm. The investigators followed-up 3,6,12,24 months of the change of BMI,FBG,HbA1c,Blood pressure,Blood fat after surgery.

Official Title
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The Curative Effect of the Length of the Jejunum Exclusion in Grstric Bypass Surgery for Type 2 Diabetes:a Randomized Controlled Trials

Conditions
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Type 2 Diabetes, Obesity

Intervention / Treatment
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* Procedure: short biliarypancreatic limb
* Procedure: long biliarypancreatic limb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 20-65 years old History of diabetes is less than 15 years Fasting c-peptide≥1.6 BMI≥21kg/m2； Ability to understand the nature of the procedure and willing to follow postoperative routine lifestyle and checkups Exclusion Criteria: Psychological and mental disorders Serious important organs such as heart and lung disease cannot be tolerated surgery Complex history of abdominal surgery in the abdominal cavity adhesion Pregnancy or lactation

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: short biliarypancreatic limb<br>short biliarypancreatic limb | Procedure: short biliarypancreatic limb<br>* biliarypancreatic limb:50cm;roux limb:150cm.<br>|
| Active Comparator: long biliarypancreatic limb<br>long biliarypancreatic limb | Procedure: long biliarypancreatic limb<br>* biliarypancreatic limb:100cm;roux limb:100cm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass idex | Changesd of BMI | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IFG | Variations of IFG | 24 months | 
| HbA1c | The changes of HbA1c | 24 months | 
| blood pressure | Changes of blood pressure including both systolic and diastolic pressure. | 24 months | 
| blood fat | Changes of blood fat including LDL, HDL, CHOL, TG | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, T2DM, RYGB