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Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Miguel Madeira, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01598233
First received: May 4, 2012
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by Federal University of 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


Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: August 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Silimed Intragastric balloon
    Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution
  Eligibility

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

Inclusion Criteria:

  • metabolic syndrome (IDF criteria)

Exclusion Criteria:

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

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

No publications provided

Responsible Party: Miguel Madeira, Principal investigator, Federal University of 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: May 15, 2012
Health Authority: Brazil: Associação Fundo de Incentivo à Pesquisa

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

ClinicalTrials.gov processed this record on May 23, 2013