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This study evaluate the Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus in grade 1 obesity and overweight patients.
A clinical trial, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus), including 50 research subjects with type 2 diabetes mellitus and obesity class I or overweight. The main objective is to analyse the effect on glycemic control after 2 years of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duodenal Ileal interposition | Experimental | Duodenal Ileal Interposition with Sleeve Gastrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duodenal Ileal Interposition with Sleeve Gastrectomy | Procedure | Laparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission of type 2 Diabetes at 24 months | Number of patients with glycated hemoglobin (HbA1c) of 6.0% or less, without use of diabetes medications | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Control of type 2 diabetes | Number of patients with glycated hemoglobin (HbA1c) < 6.5%, but still in use of oral anti diabetic drugs and/or insulin | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessment | Application of World Health Organization's Quality of Life questionnaire (WHOQOL-BREF) | Before and 1, 3, 6, 12, 18 and 24 months after surgery |
| Measurement of surgical adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonardo R Ferraz, MD | Contact | +55 21 996462422 | lrferraz1@hotmail.com | |
| Thiago B de Abreu, MD | Contact | +55 21 996487500 | boechat11@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Leonardo R Ferraz, MD | Hospital Federal de Bonsucesso | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Federal de Bonsucesso | Recruiting | Rio de Janeiro | 21041-020 | Brazil |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Use of Clavien-Dindo classification
| 2 years |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |