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Stomach Reduction with Interposition of the Small Intestine for the Treatment of Type 2 Diabetes Mellitus

Ileal interposition associated to a sleeve gastrectomy for the treatment of type 2 Diabetes Mellitus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-736xwr
Enrollment
Unknown
Registered
2018-03-27
Start date
2017-09-21
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus, Obesity

Interventions

The patient will undergo general anesthesia. Prophylactic antibiotic therapy. The procedures will be performed by laparoscopy and / or laparotomy. The GVII surgery consists of the following steps: Pre
cavity inventory
ligation of the gastroepiploic arcade and short gastric vessels section of the stomach vertically to make the gastric reservoir of approximately 100-150 ml
section of the first duodenal portion 2 cm distal from the pylorus
section of the splanchnic nerves bilaterally with denervation along the hepatic artery and portal vein
section of the ileum at 30 cm and 200 cm from the ileocecal valve
an ileal-ileal anastomosis 30 cm from the ileocecal valve
anastomosis of the ileal segment transposed proximally with the proximal duodenal segment
anastomosis of the ileal segment transposed distally 50 cm from the Treitz angle
synthesis of the holes of the mesentery (under the entero-enteroanastomoses)
Hepatic biopsy with needle. review of surgery and synthesis of aponeurosis and skin.
Procedure/surgery
E04.210.419

Sponsors

Hospital Federal de Bonsucesso
Lead Sponsor
Hospital Federal de Bonsucesso
Collaborator

Eligibility

Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Documented diagnosis of type 2 diabetes mellitus; Patients of both sexes treated with oral antidiabetic agents and / or insulins; Stable antidiabetic medication in the last 8 weeks prior to selection, if the therapy includes insulin, the mean daily dose should not have been changed by more than 10% in the last 8 weeks; HbA1c> 7.0%; Age> 20 years and <65 years;Body mass index (BMI) of 25 to 35 kg / m²; Agree to sign the TCLE;

Exclusion criteria

Exclusion criteria: Diabetes mellitus type 1 (anti-GAD positive) or anti-GAD negative body with low ?-cell function (peptide C after stimulation <0.5 ng / ml); Recent vascular event (myocardial infarction, coronary angioplasty or encephalic vascular accident in the last 6 months); Malignant neoplasm; Portal hypertension; Difficulty to cooperate with segment; Low ability to understand surgery; Unrealistic expectations of results; Cognitive deficit; Current pregnancy; Moderate or severe mood disorder; severe anxiety; eating disorders (based on DSM-V criteria); Chemical dependence or alcoholism (based on DSM-V criteria).

Design outcomes

Primary

MeasureTime frame
To evaluate the remission rate of DM2 characterized by serum glycosylated hemoglobin (A1C) less than 6.0%, without the use of anti-diabetic drugs. To evaluate the control of DM2: HbA1c lower than 6.5% but still in use of oral antidiabetic and / or insulin.

Secondary

MeasureTime frame
To evaluate quality of life of patients before and after GVII.;To evaluate the complications of the surgical treatment.;To evaluate the evolution of other comorbidities such as hypercholesterolemia, hypertriglyceridemia, hepatic steatosis and arterial hypertensio

Countries

Brazil

Contacts

Public ContactLeonardo Ferraz

Hospital Federal de Bonsucesso

lrferraz1@hotmail.com+55 (21) 3977-9605

Outcome results

None listed

Source: REBEC (via WHO ICTRP)