MedTrace Logo

Effect of Laparoscopic Roux-en-Y Gastric Bypass Surgery on Non-severe Obesity With Type 2 Diabetes Mellitus

NCT02091323 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-01-27

No results posted yet for this study

Summary

The effect of roux-en-Y gastric bypass(RYGB) on patients with type 2 diabetes mellitus(T2DM) and a body mass index(BMI)\>35kg/m2 is clear. There are large-scale patients with T2DM in Chinese population and currently about two-thirds of them are lack of adequate blood glucose control. Asian Chinese have different type of obesity, different style of diet, and a relatively low BMI levels as well. We assess the feasibility and efficacy of laparoscopic roux-en-Y gastric bypass surgery (LRYGB) in patients with non-severely obese T2DM.Taking into account the differences of body size and diet between the United States \& Europe and Asian countries, diabetic situation has its special features in different regions, especially in Asia China. Asian Chinese have a high incidence of T2DM and a relatively low BMI levels. Evaluating the benefits from LRYGB for T2DM in Asian Chinese diabetes subjects with a body mass index of less than 35kg/m2 and looking for sufficient evidence to this operation become necessary.The patients will be followed up for one year after surgery and a comparison would be made between the two groups. Clinical indicators that reflect the effect of LRYGB are monitored before surgery and 1, 3,6,12 months after surgery. Complete remission of diabetes was defined by hemoglobin A1c (HbA1c)\<6.0% and Fasting plasma glucose (FPG)\<5.6mmol/L.

Conditions

  • Diabetes Mellitus, Non-Insulin-Dependent

Interventions

PROCEDURE

gastric bypass surgery

With the patient under intubation and general anesthesia, a pneumoperitoneum was created and the pressure was set to 15 mmHg. All LRYGB operations were performed using four trocars. Separate cardiac angle and hepatogastric ligament from the left gastric artery between 2 and 3 branch by hanging liver on the abdominal wall so as to enter into the lesser sac. Reveal the ligament of Treitz, lift the jejunum from the Treitz ligament 75 \~ 150 cm, connect the distal jejunum to the posterior wall of the stomach with a linear cutting staple by an end-to-side anastomosis and suture the common opening at last.

Sponsors & Collaborators

  • Guangzhou General Hospital of Guangzhou Military Command

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02091323 on ClinicalTrials.gov