Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miguel Madeira, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01598233
First received: May 4, 2012
Last updated: December 16, 2014
Last verified: December 2014

May 4, 2012
December 16, 2014
March 2011
January 2012   (final data collection date for primary outcome measure)
  • 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
  • Change in bone mineral density and body composition [ Time Frame: 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: 6 months ] [ Designated as safety issue: No ]
  • Change in Pulmonary function tests [ Time Frame: 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: 6 months ] [ Designated as safety issue: No ]
    Bone microarchitecture by high-resolution peripheral quantitative computed tomography
  • Change in lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol
Complete list of historical versions of study NCT01598233 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters
Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters
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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Overweight
  • Obesity
  • Metabolic Syndrome
Device: Silimed Intragastric balloon
Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution
Experimental: Intragastric balloon
Patients submitted to six-month intragastric balloon
Intervention: Device: Silimed Intragastric balloon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • metabolic syndrome (IDF criteria)

Exclusion Criteria:

  • menopause
  • older than 50 years
  • diabetes mellitus
Both
20 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01598233
3056-CEP/HUPE
No
Not Provided
Not Provided
Miguel Madeira, Universidade Federal do Rio de Janeiro
Universidade Federal do Rio de Janeiro
Not Provided
Not Provided
Universidade Federal do Rio de Janeiro
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP