NCT01598233|CompletedPhase 3
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Sponsor study identifier
interventional
50
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2012
Actual (reported)Study Completion
August 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
January 2012
Actual (reported)May 4, 2012
Actual (reported)May 15, 2012
Actual (reported)August 2012
Actual (reported)Change in bone mineral density and body composition
Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA)
Baseline and 6 months
Change in fasting and postprandial glucose
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).
Baseline and 6 months
Change in bone microarchitecture
Bone microarchitecture by high-resolution peripheral quantitative computed tomography
Baseline and 6 months
Change in lipid profile
Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol
Baseline and 6 months
Patients submitted to six-month intragastric balloon
Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Universidade Estadual do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20.551-030, Brazil
Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, de Mendonca LMC, de Godoy-Matos AF, Lopes AJ, Farias MLF. Impact of 6 months of treatment with intragastric balloon on body fat and quality of life in obese individuals with metabolic syndrome. Health Qual Life Outcomes. 2017 Oct 24;15(1):211. doi: 10.1186/s12955-017-0790-x.
Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, Mendonca LM, Godoy-Matos AF, Lopes AJ, Farias ML. Impact of a 6-month treatment with intragastric balloon on body composition and psychopathological profile in obese individuals with metabolic syndrome. Diabetol Metab Syndr. 2016 Dec 19;8:81. doi: 10.1186/s13098-016-0197-6. eCollection 2016.
50 participants (actual enrollment reported by the registry).
First Submitted
May 4, 2012
First Posted
May 15, 2012
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2012
Actual (reported)Study Completion
August 2012
Actual (reported)Last Updated
December 18, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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