Study of laparoscopic biliopancreatic diversion modality for treatment of type 2 diabetes in patients with a BMI between 30 and 35. [Estudio y resultados de una modalidad de derivación biliopancreática laparoscópica para el tratamiento de la diabetes tipo 2 en pacientes con IMC entre 30 y 35]
Completed
- Conditions
- Type 2 diabetesNutritional, Metabolic, EndocrineNon-insulin-dependent diabetes mellitus
- Registration Number
- ISRCTN59207763
- Lead Sponsor
- Aragon Institute of Health Sciences [Instituto Aragonés de Ciencias de la Salud] (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
1. Patients diagnosed with type 2 diabetes
2. Between 18 and 60 years old
3. Body mass index (BMI) between 30 and 35
4. Less than 10 years of illness evolution
5. Subject to medical treatment (oral antidiabetics, and/or insulin) and without enough control
6. More than 2 years of medical treatment and adequate pancreatic reserve (haemoglobin glycosylated determination with a result of more than 7)
Exclusion Criteria
1. Positive anti glutamic acid decarboxylase (GAD) antibodies
2. Patients diagnosed with type 2 diabetes controlled with one or two oral antidiabetics, preanesthetic evaluation between 4 or 5 Anesthetic Society of America criteria values (ASA)
3. Laparoscopic and surgery general contraindications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Normal glucose levels<br>2. Insulin blood level<br>3. Normal nutritional state assessed against calcium, iron, protein and vitamin metabolism<br>4. BMI between 20 and 30 <br>5. Quality of life
- Secondary Outcome Measures
Name Time Method 1. Insulin production related hormones evolution (GIP, GLP1, ghrelin, neuropeptide YY)<br>2. Glucose metabolism (glucagon test, basal proinsulin)