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| ID | Type | Description | Link |
|---|---|---|---|
| HSL 2012-01 | Other Identifier | CEPesq Register Number | |
| 00747112.3.0000.5461 | Registry Identifier | CAAE |
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There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical, gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in a single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2 diabetes mellitus and obesity class I. In order to compare the effect of weight loss on glycemic control among medical and surgical groups, and after 2 years of follow up, the results of efficacy, safety and maintenance will be compared between the three groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical | Active Comparator | Subject submitted to clinical obesity treatment |
|
| Gastric bypass surgery | Active Comparator | Subjects submitted to Gastric Bypass Surgery |
|
| Surgical ileal transposition with sleeve | Active Comparator | Subjects submitted to surgical ileal transposition with sleeve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric bypass surgery | Procedure | Gastric bypass surgery performed laparoscopically |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic blood rates | Comparison of efficacy and safety in glycemic control between the medical and surgical treatment. | In 2 years |
| Glycemic blood rates | Comparison of efficacy and safety in glycemic control between the two surgical modalities. | In 2 years |
| Diabetes remission evaluated by patients glycemic rates | Comparison of diabetes remission between the two surgical modalities. | In 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Comparison of efficacy in the control of overweight in the medical and surgical treatment. | In 2 years. |
| Decrease in blood lipid | Comparison of the effectiveness in controlling lipid between the medical and surgical treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Cozer, Md | Hospital Sirio-Libanes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sírio Libanês Teaching and Research Center | São Paulo | São Paulo | 01308060 | Brazil |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Surgical ileal transposition with sleeve | Procedure | Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery. |
|
| Clinical | Other | The study subjects allocated for clinical treatment will have these treatment divided into three phases. The first one based on glycemic control through weight loss, the second one based on anti-hyperglycemic medications and the last one based on medical monitoring for a further twelve months for the maintenance of the results. |
|
| In 2 years |
| Quality of life evaluation | Comparison of quality of life between the medical and surgical treatment through specific interviews | In 2 years |
| Number of Early Adverse Events | Comparison of early complications between the two surgical modalities. | In 2 years |
| Number os Nutricional Complications | Comparison of nutritional complications between the two surgical modalities. | In 2 years |
| Number of Late Adverse Events | Comparison of late complications between the two surgical modalities. | In 2 years |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |