Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

Phase 3

Completed

• Conditions: Overweight; Obesity; Metabolic Syndrome
• Interventions: Device: Silimed Intragastric balloon

• Registration Number: NCT01598233
• Lead Sponsor: Universidade Federal do Rio de Janeiro

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-01
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-11
• Study First Posted: 2012-05-15
• Study Completion: 2012-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• metabolic syndrome (IDF criteria)

Exclusion Criteria

• menopause
• older than 50 years
• diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intragastric balloon	Silimed Intragastric balloon	Patients submitted to six-month intragastric balloon

Primary Outcome Measures

Name	Time	Method
Change in bone mineral density and body composition	Baseline and 6 months	Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA)
Change in fasting and postprandial glucose	Baseline and 6 months
Change in Pulmonary function tests	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	Baseline and 6 months	Bone microarchitecture by high-resolution peripheral quantitative computed tomography
Change in lipid profile	Baseline and 6 months	Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol

Trial Locations

Locations (1)

Universidade Estadual do Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil