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Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

Primary Purpose

Overweight, Obesity, Metabolic Syndrome

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Silimed Intragastric balloon
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • metabolic syndrome (IDF criteria)

Exclusion Criteria:

  • menopause
  • older than 50 years
  • diabetes mellitus

Sites / Locations

  • Universidade Estadual do Rio de Janeiro

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intragastric balloon

Arm Description

Patients submitted to six-month intragastric balloon

Outcomes

Primary Outcome Measures

Change in bone mineral density and body composition
Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA)
Change in fasting and postprandial glucose
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).
Change in bone microarchitecture
Bone microarchitecture by high-resolution peripheral quantitative computed tomography
Change in lipid profile
Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol

Secondary Outcome Measures

Full Information

First Posted
May 4, 2012
Last Updated
December 16, 2014
Sponsor
Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT01598233
Brief Title
Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters
Official Title
Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intragastric balloon
Arm Type
Experimental
Arm Description
Patients submitted to six-month intragastric balloon
Intervention Type
Device
Intervention Name(s)
Silimed Intragastric balloon
Intervention Description
Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution
Primary Outcome Measure Information:
Title
Change in bone mineral density and body composition
Description
Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline and 6 months
Title
Change in fasting and postprandial glucose
Time Frame
Baseline and 6 months
Title
Change in Pulmonary function tests
Description
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).
Time Frame
Baseline and 6 months
Title
Change in bone microarchitecture
Description
Bone microarchitecture by high-resolution peripheral quantitative computed tomography
Time Frame
Baseline and 6 months
Title
Change in lipid profile
Description
Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: metabolic syndrome (IDF criteria) Exclusion Criteria: menopause older than 50 years diabetes mellitus
Facility Information:
Facility Name
Universidade Estadual do Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
20.551-030
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29065923
Citation
Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, de Mendonca LMC, de Godoy-Matos AF, Lopes AJ, Farias MLF. Impact of 6 months of treatment with intragastric balloon on body fat and quality of life in obese individuals with metabolic syndrome. Health Qual Life Outcomes. 2017 Oct 24;15(1):211. doi: 10.1186/s12955-017-0790-x.
Results Reference
derived
PubMed Identifier
28031749
Citation
Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, Mendonca 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.
Results Reference
derived

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Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

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