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Researchers at the Heart Institute (Incor) - hospital belonging to the Faculty of Medicine, University of São Paulo (USP) - seeking volunteers for a study that aims to evaluate the effect of bariatric surgery in the control of cardiovascular risk factors in overweight or diabetic patients mild obesity.
Candidates must have a body mass index (BMI) between 28 and 35. Currently, according to the determination of the Federal Medical Council, may undergo the procedure only people with a BMI above 40 or above 35 for diseases associated with obesity such as diabetes and hypertension.
Preference was given to people with a BMI below 35 in the project because, according to some studies indicate diabetes in these patients is less linked to obesity and related to a more favorable metabolic profile, explained Fernanda Reis de Azevedo, whose estudo of PhD Scholarship has the support of FAPESP.
Recent investigations have also shown that diabetics have better glycemic operated even before the occurrence of a significant weight loss, she added. Our goal is to understand what are the metabolic changes involved and measure the impact on cardiovascular risk reduction, said.
The study is linked to the Thematic Project Intermittent Fasting and adaptation digestive surgery: evaluation of translational effects on cardiovascular risk factors and atherogenesis, coordinated by Professor Bruno FMUSP Caramelli.
According Azevedo, poorly controlled diabetes contributes in several ways to increase cardiovascular risk. The constant elevation of blood glucose attacks the wall of arteries and promotes the development of atherosclerosis. The renal disease also have consequences which can cause increased blood pressure.
Some patients are unable to maintain blood glucose under control even with insulin, diet and medicine. We seek to study precisely these patients with decompensated disease, he said.
Candidates must also be between 18 and 65 years, waist circumference above 102 centimeters and being male. We leave women out, because the hormonal changes related to the menstrual cycle may affect results, Azevedo said.
Moreover, volunteers must have been diagnosed with diabetes for more than two years and less than ten. Can not be dependent on alcohol, cigarettes or drugs or be carriers of serious chronic diseases unrelated to obesity, such as cancer, AIDS and autoimmune disorders.
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The goal is to select 20 candidates. Another ten healthy volunteers will be part of the study to serve as a metabolic parameter. Let us to evaluate the release of hormones produced in the gastrointestinal tract, such as leptin and ghrelin GLP1, which is a potent inducer of satiety and also increases insulin sensitivity, said Azevedo.
Those selected will undergo a consultation with an endocrinologist to enhance clinical treatment. After six weeks, there will be a raffle of ten people who will be operated. The other ten volunteers will follow only with medical therapy.
Before surgery, all will undergo a battery of tests, including blood collection, echocardiography, ultrasound and CT. Let's evaluate blood glucose, cholesterol, atherosclerotic plaques throughout the body and if there is fat accumulation in the liver and around the heart, Azevedo said.
The second battery of tests will be conducted three months after the operation and the third two years later. With all the data in hand we can calculate cardiovascular risk and see which group he fell over, he said.
Those interested in participating in the study can contact by phone at (11) 2661-5376 or by e-mail freis@usp.br.