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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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Introduction- Primary prevention is the main strategy to control the global burden of cardiovascular disease. In clinical practice, food restriction represents a valuable preventive resource. However, low adhesion rates and diet abandonment are considered important obstacles in treatment. Considering the discovery of new markers and mechanisms that relate food restriction and to all other cardiovascular risk factors, it is possible and necessary to seek for efficient alternatives to increase adherence and effectiveness of the preventive dietetic treatment. Surgical procedures can be used as a mechanism to promote food restriction. The bariatric surgery have gained importance not only for its potential application in obesity treatment but also in the control of cardiovascular risk factors refractory to medical treatment. Among bariatric operations, there is a group called digestive adaptations III that has specific characteristics.This surgical intervention modifies intestinal tract by reducing gastric volume and performing an anastomosis between ileum and stomach, creating a bipartition in the gut. This structural modification promotes satiety and increased insulin sensitivity more intensely than other surgical strategies. The effects of Digestive Adaptation III surgery on cardiovascular risk factors and on markers related to the development of atherosclerosis are not yet established.
Objectives - To investigate the effect of Digestive Adaptation III surgery on clinical and laboratory parameters and cardiovascular risk factors.
Methods - Twenty diabetics volunteers refractory to medical treatment and who have abdominal obesity will be included in the study. Of this group, half will be randomly selected to perform the Digestive Adaptations III surgery. All participants will undergo clinical and biochemical tests on the same occasions, up to thirty days before surgery, three twenty-four months after surgery. On these occasions besides the lipid profile and glucose, we will determine incretin hormones, adipokines and assess the amount of epicardial fat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical treatment | Diabetic individuals refractory to medical treatment kept under clinical treatment guidelines and lifestyle | ||
| Surgery | Diabetic individuals refractory to conservative clinical treatment subject to Digestive Adaptations III Surgery. |
| |
| Control | Healthy individuals (normal weight and no cardiovascular risk factors) will be used to evaluate the behavior incretin hormones in healthy individuals, serving as a benchmark to analyze the results obtained in other groups. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digestive Adaptations III surgery | Procedure |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Metabolic Profile | Modification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk. | two years |
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Inclusion Criteria:
Exclusion Criteria:
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The population will be selected in a primary care clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Caramelli, Ph.D. | University of Sao Paulo | Study Chair |
| Fernanda R Azevedo, Nutr | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute - University of São Paulo | São Paulo | 05403-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29704228 | Derived | Azevedo FR, Santoro S, Correa-Giannella ML, Toyoshima MT, Giannella-Neto D, Calderaro D, Gualandro DM, Yu PC, Caramelli B. A Prospective Randomized Controlled Trial of the Metabolic Effects of Sleeve Gastrectomy with Transit Bipartition. Obes Surg. 2018 Oct;28(10):3012-3019. doi: 10.1007/s11695-018-3239-3. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Whole blood samples will be retained for future exams.
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |