Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

Obesity Clinical Trial

Official title:

Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598233
• Other study ID #: 3056-CEP/HUPE
• Status: Completed
• Phase: Phase 3
• First received: May 4, 2012
• Last updated: December 16, 2014
• Start date: March 2011
• Est. completion date: August 2012

Study information

• Verified date: December 2014
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à Pesquisa
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• metabolic syndrome (IDF criteria)

Exclusion Criteria:

• menopause

• older than 50 years

• diabetes mellitus

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Overweight

Intervention

Device:
• Silimed Intragastric balloon
Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution

Locations

Country	Name	City	State
Brazil	Universidade Estadual do Rio de Janeiro	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone mineral density and body composition	Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA)	Baseline and 6 months	No
Primary	Change in fasting and postprandial glucose		Baseline and 6 months	No
Primary	Change in Pulmonary function tests	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).	Baseline and 6 months	No
Primary	Change in bone microarchitecture	Bone microarchitecture by high-resolution peripheral quantitative computed tomography	Baseline and 6 months	No
Primary	Change in lipid profile	Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol	Baseline and 6 months	No