Clinical trial NCT02667652: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Keywords: T2DM
RYGB
RCT
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: body mass idex
timeFrame: 24 months
Secondary outcomes:
measure: IFG
timeFrame: 24 months
measure: HbA1c
timeFrame: 24 months
measure: blood pressure
timeFrame: 24 months
measure: blood fat
timeFrame: 24 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping hospital
state: Chongqing
Study officials:
affiliation: Daping Hospital, Third Military Medical University
name: Tong Weidong, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.