The purpose of this study is to evaluate the effects of intragastric balloon on bone, metabolic and respiratory parameters in 50 patients with metabolic syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution
Universidade Estadual do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
Change in bone mineral density and body composition
Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline and 6 months
Change in fasting and postprandial glucose
Time frame: Baseline and 6 months
Change in Pulmonary function tests
Pulmonary function tests consiste of spirometry, body plethysmograph, diffusing capacity for carbon monoxide (DLco), and respiratory muscle strength. Measurements are conducted using the Collins Plus Pulmonary Function Testing Systems (Warren E. Collins, Inc., Braintree, MA, USA).
Time frame: Baseline and 6 months
Change in bone microarchitecture
Bone microarchitecture by high-resolution peripheral quantitative computed tomography
Time frame: Baseline and 6 months
Change in lipid profile
Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol
Time frame: Baseline and 6 months
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