Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Friendship Hospital
About this trial
Diabetes mellitus (T2DM) is the most common complication of obesity patients. According to previous literature reports, weight loss and metabolic surgery are powerful means to treat obesity complicated with T2DM. Roux-en-Y gastric bypass (RYGB) is the standard operation recommended by the international society. One-anastomosis gastric bypass (OAGB) was recommended by IFSO（the International Federation for the Surgery of OBESITY AND METABOLIC DISORDERS ） in 2018.
In this study, two kinds of metabolic surgery will be compared. At present, focusing on the above two operations, only two effective randomized controlled clinical studies have been carried out, among which one single-center clinical study has been followed up for 2 years, and the primary end point is weight loss; Another multicenter study, with a 2-year follow-up, showed that the primary end point was weight loss, and the secondary index was the effectiveness of two surgical methods in the treatment of T2DM.There is still a lack of evidence-based evidence for the effectiveness and safety of the two surgical methods in the treatment of T2DM. This study will make high-level evidence about the advantages and disadvantages of OAGB and RYGB in the treatment of T2DM.
In this study, a number of centers with rich experience and clinical research experience in weight loss and metabolic surgery in Asia will be combined to complete the enrollment of 248 patients. Those who meet the standards will be randomly divided into two kinds of operations, and they will be followed up for 5 years on schedule. The rate of lost follow-up is controlled within 20%, and the data integrity is controlled within 95%. Taking the blood glucose remission rate of type 2 diabetes as the main observation index, the prospective verification shows that OAGB is clinically effective in treating obesity with type 2 diabetes compared with RYGB.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
21-65 years old, Male/Female, East Asian population
50 kg/m2≥BMI≥27.5kg/m2
Type 2 diabetes duration ≥6 months
HbA1c≥7.0%
Disqualifiers
Underwent gastrointestinal surgery (gastric/duodenal surgery or bariatric surgery)
Fasting C-peptide level lower than 1/2 normal minimum
Active gastrointestinal ulcer is present
Helicobacter pylori infection is present
Trial design
Design model
Parallel
Treatments tested in this trial
The laparoscopic One-anastomosis gastric bypass will consist of:
Procedure/Surgerygastrointestinal anastomosis: anterior colon and posterior stomach gastrointestinal anastomosis size: diameter \< 1.5cm, linear anastomosis length 2.5cm biliary and pancreatic branches 200cm, food branches 100cm exact relationship with mesangial defect
The laparoscopic Roux-en-Y gastric bypass will consist of:
Procedure/Surgerythe laparoscopic Roux-en-Y gastric bypass gastric sac size \< 30ml gastrointestinal anastomosis: anterior colon and posterior stomach gastrointestinal anastomosis size: diameter \< 1.5cm, linear anastomosis length 2.5cm biliary and pancreatic branches 50cm, food branches 150cm exact relationship with mesangial defect
Treatment groups
248 Participants
are divided into 2 treatment groupsGroup A: Laparoscopic One-anastomosis gastric bypassExperimental treatment 1 intervention
Group B: Laparoscopic Roux-en-Y gastric bypassActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
One year after operation, the complete remission rate of type 2 diabetes mellitus [HbA1c < 6%, fasting plasma glucose < 5.6 mmol/L, no need to use any hypoglycemic drugs]
Complete remission of type 2 diabetes mellitus: the blood sugar HbA1c\<6.0% and fasting plasma glucose\< 5.6 mmol/L can be controlled only by changing lifestyle intervention without taking hypoglycemic agents after operation. Partial remission: blood glucose can be controlled only by changing lifestyle intervention after operation. HbA1c\<6.5%, fasting plasma glucose 5.6\~6.9mmol/L, and blood glucose 7.8\~11.0mmol/L 2 hours after meal. Failure: blood sugar was relieved once, and then returned to the preoperative level.Unified OGTT measurement method
Time frame
1 year after surgerySecondary outcomes
1
The remission rate of type 2 diabetes mellitus
\[HbA1c \< 6%, with or without hypoglycemic drugs\] Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
Time frame
5 years after surgery2
The change of HbA1c
Changes of glycosylated hemoglobin (HbA1c) compared with baseline.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
Time frame
5 years after surgery3
HbA1c value
The value of HbA1c.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
Time frame
5 years after surgery4
The change of fasting blood glucose
Changes of fasting blood glucose compared with baseline.Visit 1: Baseline Visit (Day 0-1) Visit 2:Post-op 1 month (+7 Days) Visit 3: Post-op 3 months(+7 Days) Visit 4: Post-op 6 months(14 Days) Visit 5: Post-op 12 months (+30 Days) Visit 6：Post-op 24 months (±30 Days) Visit 7:Post-op 36 months (±30 Days) Visit 8：Post-op 60 months (±30 Days)
Time frame
5 years after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Friendship Hospital
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
The Third People's Hospital of Chengdu
Collaborator
Taipei Medical University Hospital
Collaborator
Source ClinicalTrials.gov