The weight loss and anti-diabetes outcomes of Sleeve Gastrectomy with Transit Bipartition (SG-TB) and Standard Sleeve Gastrectomy (SG) surgery

Not Applicable

• Conditions: Obesity with or without type-2 diabetes mellitus; Nutritional, Metabolic, Endocrine; Obesity, type-2 diabetes mellitus

• Registration Number: ISRCTN13129514
• Lead Sponsor: Affiliated Hospital of Xuzhou Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-24
• Last Update Posted: 3 August 2020
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age 18-65 years old
2. BMI =27.5 kg/m²

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> At surgery, 1-year and 5-year follow-up<br> 1. Weight (kg)<br> 2. BMI (weight, kg divided by the square of height, m)<br> 3. Percentage of Excess BMI Loss, %EBMIL ([(preoperative BMI – postoperative BMI) / (Preoperative BMI – 25)] x 100%”)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Diabetes Remission measured at surgery, 1-year and 5-year follow-up using:<br> 1.1. Fasting blood glucose, HbA1C (blood test)<br> 1.2. Anti-diabetic drug usage (patient records)<br>