Metabolic surgery for body mass index (BMI) < 27 kg/m2 patients with type 2 diabetes mellitus
Completed
- Conditions
- Type 2 diabetes MellitusNutritional, Metabolic, EndocrineNon-insulin-dependent diabetes mellitus
- Registration Number
- ISRCTN56897851
- Lead Sponsor
- EDa Hospital (Taiwan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
1. Age 18-65 years
2. BMI < 27 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 next 2 years
3. Patients with type 1 diabetes mellitus (T1DM)
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 1. Remission of T2DM, defined by HbA1c < 6.5% without oral hypoglycemic drugs or insulin<br>2. Glycemic control, defined as HbA1C of < 7 % despite no use of anti-diabetic medications<br>3. Improvement of 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. Failure of surgical procedure, defined as no significant improvement or worsened if a patient required an additional anti-diabetic meditation
- Secondary Outcome Measures
Name Time Method 1. Resolution of co-morbities<br>2. Complications related to procedure