Metabolic Syndrome, Obesity, Overweight
Conditions
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.
Interventions
DEVICESilimed Intragastric balloon
Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution
Sponsors
Universidade Federal do Rio de Janeiro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* metabolic syndrome (IDF criteria)
Exclusion criteria
* menopause * older than 50 years * diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed