obesity, Morbid
Conditions
Interventions
30 patients with morbid obesity and type II diabetes will be submitted to bariatric surgery randomly divided into 3 groups: Group 1 (Roux-en-Y gastric bypass with 100 cm biliopancreatic limb and 100-c
Procedure/surgery
Sponsors
Centro de Estudos do Aparelho Digestivo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: age between 18 and 65 years ; BMI higher than 30 ; DM2 confirmed by, in treatment HbA1C higher than 7,1, not in treatment, glyacemia higher than 200mg/dl or HbA1C higher than 7,1 ; Has the ability to understand treatment options and commit to the necessary treatment requirements ; Has willingness to participate in the study and agrees with all treatment arms offered in the study
Exclusion criteria
Exclusion criteria: Previous bariatric procedure ; Anterior complex abdominal surgical procedure ; Cardiovascular impairment including coronary heart disease, cardiac arrhythmias, congestive heart failure, history of stroke, chronic peripheral arterial obstruction ; Renal failure with Creatinine higher than 1.8 mg / dl ; History of chronic liver disease ; Known gastrointestinal disorders including celiac disease, inflammatory bowel disease or other malabsorptive diseases ; Psychiatric disorders including dementia, severe depression, history of suicide attempt, alcohol and drug abuse in the past 12 months ; Pregnant women ; History of neoplastic diseases in the last 5 years ; Previous history of coagulopathies, including DVT and PTE ; Severe lung disease with FEV1 lower than 50% ; ASA IV ; Total extension of the small intestine loops in length that does not allow the surgical technique to be performed for the group that the patient was assigned, maintaining a length of common limb greater than 300cm( does not apply for Sleeve Gastrectomy, since all the limbs are alimentary)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find, after 6 months of the surgery, a higher increase in the serum concentration of GIP, GLP-1, PYY, FGF-19 evaluated by a 5-time serum curve (0, 30, 60, 90, 120 min) after a mixed meal as the food stimulus occurs more distally. In decreasing order, the expected result is a greater stimulus for Sleeve Gastrectomy with Transit Bipartition followed by Roux en Y Gastric Bypass with 200cm biliopancreatic limb and lastly Roux en Y Gastric Bypass with 100cm biliopancreatic limb. It is expected to find the opposite in relation to the serum levels of ghrelin and leptin, evaluated in the same way | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find improvement in the serum levels of HbA1C assessed by laboratory tests in the preoperative periods, at 6 months and 1 year after surgery in the 3 groups. In the comparison between groups, it is expected that the Vertical Gastrectomy with Transit Bipartition presents the most expressive results followed by Roux en Y Gastric Bypass with 200cm biliopancreatic lim and finally Roux en Y Gastric Bypass with 100cm biliopancreatic limb;It is expected to find a expressive excess weight loss, assessed antropométricos measures, in the preoperative periods, at 6 months and 1 year after surgery in the 3 groups. In the comparison between groups, it is expected that the Vertical Gastrectomy with Transit Bipartition presents the most expressive results followed by Roux en Y Gastric Bypass with 200cm biliopancreatic lim and finally Roux en Y Gastric Bypass with 100cm biliopancreatic limb;It is expected to find a a improvement in the insulin sensibility and in the Beta cells functionality, assessed by serif concentration of insulin, glycaemia and C peptide, in the preoperative periods and at 6 months after surgery in the 3 groups. In the comparison between groups, it is expected that the Vertical Gastrectomy with Transit Bipartition presents the most expressive results followed by Roux en Y Gastric Bypass with 200cm biliopancreatic lim and finally Roux en Y Gastric Bypass with 100cm biliopancreatic limb;It is expected to find an increase in the density of L-cell population assessed by immunohistochemistry of small intestine biopsies as one walks distally in the small intestine;It is expected to find an increase in the density of the L-cell population assessed by immunohistochemistry 6 months after surgery at the same sites previously studied. | — |
Countries
Brazil
Contacts
Public ContactFilippe;Marco Mota;Santo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo;Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed