A Phase 3 interventional study of Duodenojejunal bypass and Sleeve gastrectomy in Diabetes Mellitus, Type 2, Bariatric Surgery and Surgical Procedures, Operative, sponsored by Seoul National University Bundang Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-27.
Sponsored by Seoul National University Bundang Hospital · Phase 3, Interventional, and Treatment
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
Most Asian patients undergoing metabolic surgery for the treatment of T2DM have BMI as low as 30-35 kg/m2. If SG is performed for the treatment of T2DM in these patients, weight may decrease after the surgery; however, T2DM may recur after 6 months to 1 year. Therefore, it is difficult to find clinical studies on SG for metabolic surgery in Asians, and gastric bypass may be more appropriate as metabolic surgery. However, gastroscopy for the remnant stomach after gastric bypass is practically impossible. Therefore, gastric bypass may be a fatal drawback for East Asian patients with a high incidence of gastric cancer. In recent years, modified duodenal switch (SG with duodenojejunal bypass [DJB], which is defined as the procedure that makes jejunal bypass shorter than the traditional duodenal switch) is often performed as metabolic surgery, and studies on this surgical technique are being actively conducted in Japan.
SG with DJB has both effects of stomach restriction and foregut bypass. However, SG with DJB is more disadvantageous compared to SG alone in nutrient absorption after surgery. This is a natural result of bypassing the duodenum and proximal jejunum. Therefore, SG with DJB should not be performed when it is unnecessary, and it should be performed in patients who are expected to show significant improvement in T2DM. However, there is no existing guideline on which patients can receive SG with DJB or SG alone, and there are also no clinical studies on these aspects.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 130 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergoing sleeve gastrectomy
Procedure: Sleeve gastrectomy
Patients undergoing duodenojejunal bypass with sleeve gastrectomy
Procedure: Duodenojejunal bypass
Sleeve 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 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
Time frame: 5 years after surgery
Complete remission rate of type 2 diabetes
HbA1c \<6% (or fasting blood glucose \[FBG\] \<100 mg/dL) without using any diabetes medication
Time frame: 1, 3, 10 years after surgery
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
Time frame: 1, 3, 5, 10 years after surgery
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.
Time frame: 1, 3, 5, 10 years after surgery
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
Time frame: 1, 3, 5, 10 years after surgery
Hypertension improvement rate
Definition of improvement of hypertension: Decrease in the number or dose of BP medications or decreased BP while taking medication
Time frame: 1, 3, 5, 10 years after surgery
Hyperlipidemia remission rate
Definition of remission of hyperlipidemia: Normal lipid profile (triglyceride \[TG\] \<150 mg/dL and low-density lipoprotein \[LDL\] of 129 mg/dL or less and high-density lipoprotein \[HDL\] of 40 mg/dL or above) without taking hyperlipidemic drugs
Time frame: 1, 3, 5, 10 years after surgery
Hyperlipidemia improvement rate
Definition of improvement of hyperlipidemia: Reduced number or dose of hyperlipidemic drugs or improved lipid profile while taking hyperlipidemic drugs
Time frame: 1, 3, 5, 10 years after surgery
Prevalence of GERD
Acid reflux symptoms and positive endoscopic findings (LA classification A or more)
Time frame: 1, 3, 5, 10 years after surgery
Trace element deficiency rate (iron, vitamin B12, folate, vitamin B1, vitamin D, copper [Cu], and zinc [Zn])
Iron deficiency: ferritin \<20 ng/mL or iron \<50 mcg/dL Vitamin B12 deficiency: \<200 pg/mL, vitamin B12 suboptimal: 200 - \<400 pg/mL Folate deficiency: \<10nmol/L (4.4ng/mL) Vitamin B1 deficiency: \<2.36 mcg/dL Vitamin D deficiency: \<20 mg/mL, vitamin D insufficiency: 20-\<30 ng/mL Cu deficiency: \<75 mcg/dL Zn deficiency: \<70 mcg/dL in women, \< 74 mcg/dL in men
Time frame: 1, 3, 5, 10 years after surgery
Changes in body weight
kilograms
Time frame: 1, 3, 5, 10 years after surgery
Changes in body composition
body fat percentage(%), body fat mass (kg), and muscle mass(kg)
Time frame: 1, 3, 5, 10 years after surgery
Changes in Quality of life
IWQOL-Lite, SF-12
Time frame: 1, 3, 5, 10 years after surgery
Early complication rate
Time frame: Early: within 30 days after surgery
Late complication rate
Time frame: Late: later than 30 days after surgery
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Seoul National University Bundang Hospital