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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667652
• Other study ID #: 776117
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2020

Study information

• Verified date: May 2022
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Procedure:
• short biliarypancreatic limb
biliarypancreatic limb:50cm;roux limb:150cm.
• long biliarypancreatic limb
biliarypancreatic limb:100cm;roux limb:100cm.

Locations

Country	Name	City	State
China	Daping hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Weidong Tong

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body mass idex	Changesd of BMI	24 months
Secondary	IFG	Variations of IFG	24 months
Secondary	HbA1c	The changes of HbA1c	24 months
Secondary	blood pressure	Changes of blood pressure including both systolic and diastolic pressure.	24 months
Secondary	blood fat	Changes of blood fat including LDL, HDL, CHOL, TG	24 months