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Evaluation of effectiveness of intragastric balloon associated with diet in the treatment of diabetic patients with BMI <35

Grant number: 16/12669-0
Support type:Regular Research Grants
Duration: September 01, 2016 - August 31, 2018
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Rosa Ferreira dos Santos
Grantee:Rosa Ferreira dos Santos
Home Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
Assoc. researchers:Eduardo Guimarães Hourneaux de Moura ; Maria Elizabeth Rossi da Silva ; Silvia Mansur Reimão

Abstract

On the last decade obesity is a chronicle disease which has become one of the biggest health problem on the last decades. Considered pandemic XXI century, it leads morbidity causes and early death. Affects about 1,8 billion people around the world. It is associated with other diseases, including high blood pressure , type 2 diabetes, cardiovascular risk, hyperlipidemia, obstructive sleep apnea, osteoarthritis, neoplasia,psychosocial problem, and compromising quality of life.The etiology of obesity is multifactorial, which makes the success of treatment even harder. The intragastric balloon is an effective method for short-term and a non-surgical intervention. Furthermore, it is a restrictive procedure and completely reversible at any time, with the balloon removal. It is also considered a method that facilitates learning new eating and behavioral habits.Blood pressure and serum glucose measurements, insulin, cholesterol, triglycerides,C-reactive protein and level of glycated hemoblogina (diabetic) reduce with the placement of the balloon in addition to the weight loss and consequent improvement in quality of life. The gastrointestinal tract is the largest endocrine organ in the body as secret many gut hormones, such as peptide YY (PYY) and glucagon-like peptide 1 (GLP-1), which are extremely important in maintaining energy balance and control body weight. PYY levels increase after food intake and reached the maximum level after 1 to 2 hours and remained high over a long period, suggesting to have an important role in satiety. GLP-1 is a hormone that has anorectic action and the main stimulus for secretion is the food intake. By presenting peripheral receptors and short half-life of about 2 minutes it is considered an important factor to indicate the end of the meal and give the feeling of satiety. However, it is not known the exact mechanism of secretion and inhibition. Thus, PYY and GLP-1 have been extensively studied for the treatment of obesity. Until the present time, there are no studies in the literature to assess the impact of the use of intragastric balloon in the secretion of PYY and GLP-1.Objectives: To evaluate the effectiveness of intragastric balloon for the treatment of obesity and diabetes and analyze hormone changes (PYY and GLP-1) in these patients. Methods: Prospective, longitudinal, clinical trial.40 patients with body mass index 27-35 and diabetes were selected. Intragastric balloon was placed and left for a period of 6 months. After removal of the balloon, patients are followed for another 6 months, totaling 12 months of study for each patient. A standardized test meal of 500 kcal diet was carried out at 0 and 6 months, Glucose, insulin and triglycerides at times 0, 30, 60, 120 and 180 minutes. Blood samples were collected in these 5 times to perform dosages of PYY and GLP-1.Partial results : From 40 selected patients, 28 have completed the study and 12 are still been studied. We intend to complete the study in four months. Regarding the profile of the patients, 36 were female and the average age is 45 years. The weight loss was 17.89% of the total initial weight and 55.66 % of overweight. Most patients could be maintained without hypoglycemic agents. Glucose, insulin and triglyceride levels decreased and were statistically significant when compared before and after through the area under the curve (graphics and tables are attached). (AU)