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

May 5, 2022 updated by: Weidong Tong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Daping Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: short biliarypancreatic limb
Procedure: short biliarypancreatic limb
biliarypancreatic limb:50cm;roux limb:150cm.
Active Comparator: long biliarypancreatic limb
Procedure: long biliarypancreatic limb
biliarypancreatic limb:100cm;roux limb:100cm.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weidong Tong

Investigators

  • Principal Investigator: Tong weidong, Professor, Daping Hospital, Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 776117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Ethics Committee of Daping Hospital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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