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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intragastric balloon | Experimental | Patients submitted to six-month intragastric balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silimed Intragastric balloon | Device | Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in fasting and postprandial glucose | Baseline and 6 months | |
| 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 |
| Change in bone microarchitecture | Bone microarchitecture by high-resolution peripheral quantitative computed tomography | Baseline and 6 months |
| Change in lipid profile | Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Estadual do Rio de Janeiro | Rio de Janeiro | Rio de Janeiro | 20.551-030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29065923 | Derived | 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. | |
| 28031749 |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |