Type 2 Diabetes Clinical Trial
Official title:
Soccer and Health: Impact of Nutritional Intervention and Recreational Soccer Training in Patients With Type 2 Diabetes Mellitus
The present study aims to evaluate the impact of a soccer training program lasting 12 weeks in patients with type 2 diabetes mellitus. 60 sedentary adults and elderly patients with type 2 diabetes mellitus (age: 50-75 y), with a BMI > 25kg/m2 and > 29kg/m2, respectively, from the Hospital of the Medical Faculty of São Paulo University will participate in this study. They will be randomly divided in 3 groups (soccer, running and control). All patients will undergo the following assessments: anthropometric, dietary, physical performance, inflammatory, metabolic and hormonal parameters such as gene expression, bone markers and predictors of cardiovascular disease. In addition the investigators aim to evaluate the body composition of these patients by DXA, and muscle and visceral lipids content by proton spectroscopic MRI.
The present study aims to evaluate the regular soccer practice on cardiorespiratory fitness,
body composition, bone health and metabolic and hormonal variables, and compare it with
other types of classic aerobic training, such as running, for example .
Soccer is a high popularity team sport, with more than 400 million active practitioners in
the world, and due to various motivational and social factors of this activity we can
consider it as a great tool potential in promoting the health of sedentary individuals, but
football fans. Thus, we believe that the combined use of exercises that make up the soccer
training, such as running, walking, sprints, acceleration, deceleration, jumps, side court,
dribbling, etc., can result in significant adaptive changes in the physiological system,
contributing improvements in cardiovascular function, bone mineralization in muscle
strength, physical performance and metabolism of lipids and glucose.
Therefore we aimed to investigate in patients with diabetes mellitus type 2 the impact of a
soccer training program with 12 weeks:
- body composition, by examining DXA, assessing the content of lean mass and fat mass;
- the concentration of muscle and visceral fat by means of nuclear magnetic resonance
spectroscopy;
- the bone markers for the quantification of osteocalcin hormone, carboxy terminal
telopeptides (CTX), propeptide amino-terminal of procollagen type I (P1NP), parathyroid
hormone (PTH) and 25-hydroxy vitamin D, growth factor insulin-like-1 free ( IGF1-free);
As a secondary objective, we intend to evaluate the impact of soccer training and classic
aerobic exercise on metabolic and hormonal variables of type 2 diabetic patients:
- the parameters of cardiovascular disease, for investigating blood pressure and
quantification of lipid fractions (total cholesterol and fractions, triglycerides) and
C-reactive protein;
- physical performance, evaluating the physical capacity by examining ergospirometry;
- and the metabolic variables, enzymatic and hormonal following: blood glucose, glycated
hemoglobin (HbA1c), tolerance test oral glucose (OGTT), blood lactate, free fatty
acids, blood count, insulin, proinsulin, leptin, adiponectin, and enzymes AST, ALT, CK
and DHL.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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