Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission
- Conditions
- Complication of Bariatric ProcedureType2 Diabetes
- Registration Number
- NCT05015283
- Lead Sponsor
- Beijing Friendship Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 248
- 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%
- Currently receiving one or more oral/injectable hypoglycemic drugs (insulin /glucagon-like peptide-1 receptor agonist)
- Recommendation for OAGB/RYGB evaluated by a multidisciplinary team
- 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
- A history of serious cardiovascular and cerebrovascular diseases (myocardial infarction, stroke, etc.)
- A history of cirrhosis (Child-Pugh≥A)
- A history of chronic kidney disease (eGFR )< 60 ml/min / 1.73 m2)
- Inflammatory bowel disease is present (ulcerative colitis, Crohn's disease)
- Chronic anemia is present, Hgb for male <100g/L, for female <90g/L
- A desire to conception during the study period
- Uncontrolled mental and psychological disorders are present
- Expected survival<5 years of end-stage disease or previous/current malignant tumor
- Participated in clinical studies/trials that have the conflict of interest with the study
- Unable to understand, refuse to participate and sign the informed consent
- Gallstones require cholecystectomy
- Reflux esophagitis above grade A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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] 1 year after surgery 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
- Secondary Outcome Measures
Name Time Method Diabetes medication 5 years after surgery Follow up was used to observe whether the dosage of postoperative diabetes was reduced.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)
Change waist circumference (cm) according to absolute waist circumference 5 years after surgery Change waist circumference (cm) according to absolute waist circumference.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)
Average length of stay, based on the length of stay from operation (surgery day =day0) to the end of hospitalization 30 days after surgery Average length of stay, based on the length of stay from operation (surgery day =day0) to the end of hospitalization.Visit 1: Surgery day (day 0) record
The change of HbA1c 5 years after surgery 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)
HbA1c value 5 years after surgery 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)
Surgery time Surgery day (day 0) record Surgery time.Visit 1: Surgery day (day 0) record
The remission rate of type 2 diabetes mellitus 5 years after surgery \[HbA1c \< 6%, with or without hypoglycemic drugs\] 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)
Fasting blood glucose level 5 years after surgery The fasting blood glucose level.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)
Postoperative gastroesophageal reflux One day before surgery,5 years after surgery Evaluate according to gastroesophageal reflux disease questionnaire. The higher the score, the more likely there is gastroesophageal reflux. 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)
Fasting plasma insulin 5 years after surgery The value of fasting plasma insulin.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)
Dumping syndrome and hypoglycemia symptoms 5 years after surgery Dumping syndrome and hypoglycemia symptoms.Dumping syndrome and hypoglycemia symptoms will be evaluated by questionnaire.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)
The change of fasting blood glucose 5 years after surgery 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)
Fasting blood lipids 5 years after surgery The value of fasting blood lipids.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)
Changes of arterial blood pressure (SBP, DBP) 5 years after surgery The change of arterial blood pressure (SBP, DBP).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)
The excess weight loss (%EWL) and the total weight loss (%TWL) after surgery. 5 years after surgery %EWL=\[(initial weight)-(post-op weight)\]/\[(initial weight)-(ideal weight)\] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2),%TWL=\[(initial weight)-(post-op weight)\]/initial weight.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)
Incidence of medical and surgical complications 5 years after surgery Incidence of medical and surgical complications (anastomotic leakage, bile reflux, intestinal obstruction, anastomotic ulcer, anastomotic stenosis, internal hernia, chronic gastritis, esophagitis, iron deficiency anemia ...) Visit 1:Post-op 1 month (+7 Days) Visit 2: Post-op 3 months(+7 Days) Visit 3: Post-op 6 months(14 Days) Visit 4: Post-op 12 months (+30 Days) Visit 5：Post-op 24 months (±30 Days) Visit 6:Post-op 36 months (±30 Days) Visit 7：Post-op 60 months (±30 Days)
Incidence of surgical complications 5 years after surgery According to the grade of surgical complications, proportion of surgical complications in the total number.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)
Postoperative quality of life of patients, according to Impact Weight Quality Of Life questionnaire for weight loss surgery, scores were obtained One day before surgery,5 years after surgery According to Impact Weight Quality Of Life questionnaire for weight loss surgery, scores were obtained.The higher the score, the better the quality of life. 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)
Diarrhea frequency One day before surgery,5 years after surgery Based on gastrointestinal symptom rating scale.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)
Trial Locations
- Locations (1)
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China