Diabetes Mellitus, Obesity
Conditions
Keywords
Metabolic surgery
Brief summary
The aim of this study is to compare clinical and laboratory findings of three surgical techniques in metabolic surgery in patients with type II diabetes mellitus and obesity (BMI\> 30).
Interventions
PROCEDUREGastric bypass
PROCEDUREModified gastric bypass.
PROCEDURESlevee Gastrectomy
Sponsors
Hospital Universitario Virgen de la Arrixaca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 30-40 * Diabetes Mellitus type II less than 10 years of evolution. * Anti-GAD, anti-pancreatic islets negative antibodies. * C peptide normally between 0.9 and 4. * Glycosylated hemoglobin greater than 6.5%. * Less than 5 years of use insulin.
Exclusion criteria
* Cirrosis hepática. * coagulopathies. * Type 1 diabetes. * HIV positive. * Stomach or small intestine previous surgeries . * Diseases of the exocrine pancreas: pancreatitis, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis. * Endocrinopathies: acromegaly, glucagonoma, Cushing's syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldosteronoma. * Genetic syndromes with diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission diabetes mellitus type II | Durign two years | 1. Partial remission: Not diagnostic of DM HbA1c (\<6.5%); Basal glucose 100-125 mg / dl (5.6-6.9 mmol / l); Absence of drug treatment; At least one year. 2. Complete remission: Normal HbA1c (\<6%); basal glucose \<100 mg / dl (\<5.6 mmol / l); Absence of drug treatment; At least one year. 3. Prolonged remission: At least 5 years of remission. 4. Improvement: HbA1c \<7% with pharmacological treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | During two years | — |
| Adverse effects in the short term | During three months since surgery | We'll measure the number of patients with postoperative complications and the the degree of severity of Clavien- Dindo Classification |
| Adverse effects in the long term | Since third month after surgery untiil two years | We'll measure the number of patients with postoperative complications and the the degree of severity of Clavien- Dindo Classification |
Countries
Spain
Contacts
Primary ContactJuan A. Luján Mompean, Ph D; Section chief
Backup ContactPascual Parrilla Paricio, Ph D; Department head
Outcome results
None listed