NCT02667652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

January 26, 2016

Last Update Submit

May 5, 2022

Conditions

Type 2 DiabetesObesity

Keywords

T2DMRYGBRCT

Outcome Measures

Primary Outcomes (1)

  • body mass idex

    Changesd of BMI

    24 months

Secondary Outcomes (4)

  • IFG

    24 months

  • HbA1c

    24 months

  • blood pressure

    24 months

  • blood fat

    24 months

Study Arms (2)

short biliarypancreatic limb

ACTIVE COMPARATOR

short biliarypancreatic limb

Procedure: short biliarypancreatic limb

long biliarypancreatic limb

ACTIVE COMPARATOR

long biliarypancreatic limb

Procedure: long biliarypancreatic limb

Interventions

short biliarypancreatic limbPROCEDURE

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

short biliarypancreatic limb
long biliarypancreatic limbPROCEDURE

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

long biliarypancreatic limb

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daping hospital

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (5)

  • 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.

    PMID: 20573933BACKGROUND

  • 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.

    PMID: 22449317BACKGROUND

  • 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.

    PMID: 22449319BACKGROUND

  • 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.

    PMID: 18996751BACKGROUND

  • 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.

    PMID: 18483835BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tong Weidong, Professor

    Daping Hospital, Third Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gastric & Colorectal Division, General Surgery Dept. Daping Hospital

Study Record Dates

First Submitted

January 26, 2016

First Posted

January 29, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2019

Study Completion

August 1, 2020

Last Updated

May 11, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Ethics Committee of Daping Hospital

Locations

CN(1)