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Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01598233
First Posted: May 15, 2012
Last Update Posted: December 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Miguel Madeira, Universidade Federal do Rio de Janeiro
  Purpose
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
Overweight Obesity Metabolic Syndrome Device: Silimed Intragastric balloon Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Miguel Madeira, Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Change in bone mineral density and body composition [ Time Frame: Baseline and 6 months ]
    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 ]
  • Change in Pulmonary function tests [ Time Frame: Baseline and 6 months ]
    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 ]
    Bone microarchitecture by high-resolution peripheral quantitative computed tomography

  • Change in lipid profile [ Time Frame: Baseline and 6 months ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • metabolic syndrome (IDF criteria)

Exclusion Criteria:

  • menopause
  • older than 50 years
  • diabetes mellitus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598233


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: May 4, 2012
First Posted: May 15, 2012
Last Update Posted: December 18, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Overweight
Metabolic Syndrome X
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases