Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

Universidade Federal do Rio de Janeiro

Status and phase: Completed; Phase 3

Conditions: Overweight; Obesity; Metabolic Syndrome

Treatments: Device: Silimed Intragastric balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT01598233

3056-CEP/HUPE

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• metabolic syndrome (IDF criteria)

Exclusion criteria

• menopause
• older than 50 years
• diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intragastric balloon

Experimental group

Description:

Patients submitted to six-month intragastric balloon

Treatment:

Device: Silimed Intragastric balloon