Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

This study has been completed.
Information provided by (Responsible Party):
Miguel Madeira, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
First received: May 4, 2012
Last updated: December 16, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Metabolic Syndrome
Device: Silimed Intragastric balloon
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

Resource links provided by NLM:

Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Change in bone mineral density and body composition [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA)

  • Change in fasting and postprandial glucose [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in Pulmonary function tests [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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).

  • Change in bone microarchitecture [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Bone microarchitecture by high-resolution peripheral quantitative computed tomography

  • Change in lipid profile [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol

Enrollment: 50
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intragastric balloon
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


Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • metabolic syndrome (IDF criteria)

Exclusion Criteria:

  • menopause
  • older than 50 years
  • diabetes mellitus
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01598233

Universidade Estadual do Rio de Janeiro
Rio de Janeiro, Brazil, 20.551-030
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
  More Information

Responsible Party: Miguel Madeira, Principal investigator, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01598233     History of Changes
Other Study ID Numbers: 3056-CEP/HUPE 
Study First Received: May 4, 2012
Last Updated: December 16, 2014
Health Authority: Brazil: Associação Fundo de Incentivo à Pesquisa

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Metabolism Disorders
Insulin Resistance
Metabolic Diseases

ClinicalTrials.gov processed this record on May 24, 2016