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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
May 4, 2012
May 15, 2012
December 18, 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 ]
    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
  • Change in bone mineral density and body composition [ Time Frame: 6 months ]
    Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA)
  • Change in fasting and postprandial glucose [ Time Frame: 6 months ]
  • Change in Pulmonary function tests [ Time Frame: 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: 6 months ]
    Bone microarchitecture by high-resolution peripheral quantitative computed tomography
  • Change in lipid profile [ Time Frame: 6 months ]
    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
Intervention Model: Single Group Assignment
Masking: None (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
Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, Mendonça 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.

*   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
Sexes Eligible for Study: All
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