Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 4, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedDecember 18, 2014
December 1, 2014
10 months
May 4, 2012
December 16, 2014
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (1)
Intragastric balloon
EXPERIMENTALPatients submitted to six-month intragastric balloon
Interventions
Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution
Eligibility Criteria
You may qualify if:
- metabolic syndrome (IDF criteria)
You may not qualify if:
- menopause
- older than 50 years
- diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Estadual do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20.551-030, Brazil
Related Publications (2)
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.
PMID: 29065923DERIVEDGuedes 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.
PMID: 28031749DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 4, 2012
First Posted
May 15, 2012
Study Start
March 1, 2011
Primary Completion
January 1, 2012
Study Completion
August 1, 2012
Last Updated
December 18, 2014
Record last verified: 2014-12