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Completed

NCT Number: NCT02667652

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

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daping hospital

Chongqing, Chongqing Municipality, 400042, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

short biliarypancreatic limb

Procedure

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

long biliarypancreatic limb

Procedure

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

Primary outcomes

  1. body mass idex

    Time frame: 24 months

    Changesd of BMI

Secondary outcomes

  1. IFG

    Time frame: 24 months

    Variations of IFG

  2. HbA1c

    Time frame: 24 months

    The changes of HbA1c

  3. blood pressure

    Time frame: 24 months

    Changes of blood pressure including both systolic and diastolic pressure.

  4. blood fat

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

Weidong Tong

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jan 29, 2016
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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