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

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Procedure: long biliarypancreatic limb; Procedure: short biliarypancreatic limb

• Registration Number: NCT02667652
• Lead Sponsor: Weidong Tong

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-01-29
• Primary Completion: 2019-09
• Study Completion: 2020-08
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
long biliarypancreatic limb	long biliarypancreatic limb	long biliarypancreatic limb
short biliarypancreatic limb	short biliarypancreatic limb	short biliarypancreatic limb

Primary Outcome Measures

Name	Time	Method
body mass idex	24 months	Changesd of BMI

Secondary Outcome Measures

Name	Time	Method
IFG	24 months	Variations of IFG
HbA1c	24 months	The changes of HbA1c
blood pressure	24 months	Changes of blood pressure including both systolic and diastolic pressure.
blood fat	24 months	Changes of blood fat including LDL, HDL, CHOL, TG

Trial Locations

Locations (1)

Daping hospital; 🇨🇳 Chongqing, Chongqing, China