In this study, the effects of SG with DJB and SG alone for the treatment of type 2 diabetes mellitus (T2DM) will be compared in patients other than the two groups at both extremes who are expected to show excellent effects of metabolic surgery with SG alone (mild T2DM) and who need SG with DJB (severe T2DM).
This study is to target patients with poor blood sugar control despite current medical treatment, although the beta-cell function of the pancreas is preserved. Therefore, this study is aimed at patients who have been using insulin for less than 10 years with T2DM, or taking diabetic medications with HbA1c ≥ 7.0% for less than 10 years with T2DM.
The investigators hypothesize that the treatment effects of SG with DJB for T2DM will be superior to that of SG in this group
Age over 18 years
BMI equal to or greater than 27.5 kg/m2
T2DM duration ≤ 10 years
Using insulin, or HbA1c ≥ 7.0% while taking diabetes medication
Presence of uncontrolled severe gastroesophageal reflux (LA classification C or more in esophagogastroduodenoscopy)
History of previous metabolic surgery for T2DM
History of gastrointestinal surgery, such as gastrectomy or anti-reflux surgery, which may affect the result of metabolic surgery
Therapy regimen of more than 3 psychiatric drugs owing to poorly controlled psychiatric disorders
Parallel
Duodenojejunal bypass
Procedure/SurgerySleeve gastrectomy will be performed in the same manner as in the SG group. DJB will be performed by transection of the duodenum and bypassing 250 cm of the proximal jejunum. The handsewn suture will be used for duodenojejunal anastomosis, and the size of anastomosis will be 1.5 - 2 cm. Single anastomosis will be performed rather than Roux-en-Y fashion.
Sleeve gastrectomy
Procedure/SurgerySleeve gastrectomy will be performed using 36-38 Fr bougie. The initial stapling start point will be between 4-6 cm from the pylorus, and the last stapling will be performed at least 1 cm away from His angle. The height of the automatic stapler will be selected based on the researcher's discretion.
Complete remission rate of type 2 diabetes
HbA1c \<6% (or fasting blood glucose \[FBG\] \<100 mg/dL) without using any diabetes medication
Complete remission rate of type 2 diabetes
HbA1c \<6% (or fasting blood glucose \[FBG\] \<100 mg/dL) without using any diabetes medication
Partial remission rate of type 2 diabetes
Definition of partial remission of diabetes: HbA1c of 6-6.4% (or FBG of 100-125 mg/dL) without using any diabetes medication
Improvement rate of type 2 diabetes
Definition of improvement of diabetes: Significant reduction in HbA1c (or FBG) level or decrease in the number of diabetic drugs or stoppage of insulin that does not meet the definition of remission.
Hypertension remission rate
Definition of complete remission of hypertension: Blood pressure (BP) \<120/80 mmHg without taking BP medication Definition of partial remission of hypertension: BP of 120-140/80-89 mmHg without taking BP medication
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Seoul National University Bundang Hospital
Lead sponsor
Ajou University School of Medicine
Collaborator
The Catholic University of Korea
Collaborator
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Collaborator
Ewha Womans University Seoul Hospital
Collaborator
Seoul Metropolitan Boramae Hospital
Collaborator
Soonchunhyang University Hospital
Collaborator
Korea University
Collaborator
