Effect of Bariatric Surgery "Digestive Adaptations III" on Clinical, Laboratory and Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in Metabolic Profile
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adults (raging from 18 to 65 years).
- •Ability to understand the procedure, risks and alternatives.
- •Patients with BMI > 28 Kg/m2 and < 35 Kg/m2 presenting type 2 diabetes diagnosed for more than two years and less than 10 years.
- •Glycated hemoglobin> 8% despite dietary and medical treatment that already includes the use of exogenous insulin
- •Waist circumference > 102 cm.
排除标准
- •Chronic diseases not related to severe obesity.
- •Pregnancy.
- •Peptide C <1.5 ng / mL or a positive anti-islet antibodies, anti-GAD or anti-ICA
- •Previous cancer, unless deemed cured (after 5 years of treatment, at least)
- •Acute infection or chronic relevant.
- •Alcohol addiction.
- •Tobacco use.
- •Drug addiction, except those recovered for more than three years.
结局指标
主要结局
Improvement in Metabolic Profile
时间窗: two years
Modification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk.
次要结局
未报告次要终点
研究者
Bruno Caramelli
Director, Interdisciplinary Medicine in Cardiology Unit, Heart Institute
University of Sao Paulo
