Back to results

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

Primary Purpose

Type 2 Diabetes, Obesity

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

short biliarypancreatic limb

long biliarypancreatic limb

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring T2DM, RYGB, RCT

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Daping hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

short biliarypancreatic limb

long biliarypancreatic limb

Arm Description

short biliarypancreatic limb

long biliarypancreatic limb

Outcomes

Primary Outcome Measures

body mass idex

Changesd of BMI

Secondary Outcome Measures

IFG

Variations of IFG

HbA1c

The changes of HbA1c

blood pressure

Changes of blood pressure including both systolic and diastolic pressure.

blood fat

Changes of blood fat including LDL, HDL, CHOL, TG

Full Information

NCT ID

NCT02667652

First Posted

January 26, 2016

Last Updated

May 5, 2022

Sponsor

Weidong Tong

1. Study Identification

Unique Protocol Identification Number

NCT02667652

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

September 2019 (Actual)

Study Completion Date

August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Weidong Tong

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Obesity

Keywords

T2DM, RYGB, RCT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

short biliarypancreatic limb

Arm Type

Active Comparator

Arm Description

short biliarypancreatic limb

Arm Title

long biliarypancreatic limb

Arm Type

Active Comparator

Arm Description

long biliarypancreatic limb

Intervention Type

Procedure

Intervention Name(s)

short biliarypancreatic limb

Intervention Description

biliarypancreatic limb:50cm;roux limb:150cm.

Intervention Type

Procedure

Intervention Name(s)

long biliarypancreatic limb

Intervention Description

biliarypancreatic limb:100cm;roux limb:100cm.

Primary Outcome Measure Information:

Title

body mass idex

Description

Changesd of BMI

Time Frame

24 months

Secondary Outcome Measure Information:

Title

IFG

Description

Variations of IFG

Time Frame

24 months

Title

HbA1c

Description

The changes of HbA1c

Time Frame

24 months

Title

blood pressure

Description

Changes of blood pressure including both systolic and diastolic pressure.

Time Frame

24 months

Title

blood fat

Description

Changes of blood fat including LDL, HDL, CHOL, TG

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tong Weidong, Professor

Organizational Affiliation

Daping Hospital, Third Military Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Daping hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400042

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Ethics Committee of Daping Hospital

Citations:

PubMed Identifier

20573933

Citation

Shi Z. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Jun 24;362(25):2425; author reply 2426. doi: 10.1056/NEJMc1004671. No abstract available.

Results Reference

background

PubMed Identifier

22449317

Citation

Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Leccesi L, Nanni G, Pomp A, Castagneto M, Ghirlanda G, Rubino F. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012 Apr 26;366(17):1577-85. doi: 10.1056/NEJMoa1200111. Epub 2012 Mar 26.

Results Reference

background

PubMed Identifier

22449319

Citation

Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.

Results Reference

background

PubMed Identifier

18996751

Citation

Gleysteen JJ. Five-year outcome with gastric bypass: Roux limb length makes a difference. Surg Obes Relat Dis. 2009 Mar-Apr;5(2):242-7; discussion 247-9. doi: 10.1016/j.soard.2008.08.005. Epub 2008 Aug 19.

Results Reference

background

PubMed Identifier

18483835

Citation

Huang CK, Lee YC, Hung CM, Chen YS, Tai CM. Laparoscopic Roux-en-Y gastric bypass for morbidly obese Chinese patients: learning curve, advocacy and complications. Obes Surg. 2008 Jul;18(7):776-81. doi: 10.1007/s11695-007-9373-y. Epub 2008 May 16.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs