A Phase 3 interventional study of Silimed Intragastric balloon in Overweight, Obesity and Metabolic Syndrome, sponsored by Universidade Federal do Rio de Janeiro. Completed at 1 site in Brazil. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-12-18.
Sponsored by Universidade Federal do Rio de Janeiro · Phase 3, Interventional, and Treatment
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 50 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Universidade Federal do Rio de Janeiro is the lead sponsor of 120 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients submitted to six-month intragastric balloon
Device: Silimed Intragastric balloon
Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution
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
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Universidade Federal do Rio de Janeiro