oop Duodeno-Jejunal Bypass with Sleeve Gastrectomy for type 2 diabetes mellitus in low BMI patients
Completed
- Conditions
- Type 2 diabetes mellitusNutritional, Metabolic, EndocrineNon-insulin-dependent diabetes mellitus
- Registration Number
- ISRCTN63241920
- Lead Sponsor
- E-Da Hospital (Taiwan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1. Age 18-65 years
2. BMI < 35 kg/m2
3. Poorly controlled T2DM for at least 6 months with glycosylated haemoglobin (Hb A1C) level of >7.0%
Exclusion Criteria
1. Patients younger than 18 or older than 65 years
2. Those planning pregnancy in the next 2 years
3. Type 1 diabetes mellitus (T1DM) patients
4. Latent autoimmune diabetes in adults
5. Malignancy
6. Debilitating disease
7. Unresolved psychiatric illness
8. Substance abuse
9. American Society of Anesthesiologists (ASA) classification > III
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients will be divided into four groups on the basis of their postsurgical status: <br>1. Those in remission of T2DM, defined by HbA1c < 6.5% without oral hypoglycemic drugs or insulin<br>2. Those with glycemic control, defined as HbA1C of < 7 % despite no use of anti-diabetic medications<br>3. Those with improvement of their T2DM, defined as a reduction of at least 25% in the fasting plasma glucose level and/ or at least 1% in the pre-operative HbA1c level with hypoglycemic drug treatment<br>4. Those with failure of surgical procedure, defined as no significant improvement or worsened if a patient required an additional anti-diabetic medication
- Secondary Outcome Measures
Name Time Method 1. Resolution of co-morbidities<br>2. Complications related to procedure