Obesity with or without type-2 diabetes mellitus Nutritional, Metabolic, Endocrine Obesity, type-2 diabetes mellitus
Conditions
Interventions
The study implements a randomized controlled trial (RCT) design (1:1 ratio) involving at least 100 patients undergoing bariatric surgery in total with =50 in the sleeve gastrectomy with transit bipart
Complete remission is defined as HbA1C <6% without anti-diabetic medications and partial remission as 6-6.49%. These variables will be monitored every 6 months since surgery (at 0, 6, 12, 18, 24, 30,
Sponsors
Affiliated Hospital of Xuzhou Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years old 2. BMI =27.5 kg/m²
Exclusion criteria
Exclusion criteria: 1. Type-2 diabetes mellitus of longer than 15 years 2. Previous bariatric surgery 3. Patients debilitated with neurological, cardiovascular and/or malignancies before the procedure 4. Patients refusal to sign the consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At surgery, 1-year and 5-year follow-up 1. Weight (kg) 2. BMI (weight, kg divided by the square of height, m) 3. Percentage of Excess BMI Loss, %EBMIL ([(preoperative BMI – postoperative BMI) / (Preoperative BMI – 25)] x 100%”) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diabetes Remission measured at surgery, 1-year and 5-year follow-up using: 1.1. Fasting blood glucose, HbA1C (blood test) 1.2. Anti-diabetic drug usage (patient records) | — |
Countries
China
Outcome results
None listed