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Completed

NCT Number: NCT01598233

Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

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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Key information

Conditions

Overweight Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universidade Estadual do Rio de Janeiro

Rio de Janeiro, 20.551-030, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • metabolic syndrome (IDF criteria)

Exclusion criteria

  • menopause
  • older than 50 years
  • diabetes mellitus

Treatment and study plan

Silimed Intragastric balloon

Device

Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution

Primary outcomes

  1. Change in bone mineral density and body composition

    Time frame: Baseline and 6 months

    Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA)

  2. Change in fasting and postprandial glucose

    Time frame: Baseline and 6 months

  3. Change in Pulmonary function tests

    Time frame: 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).

  4. Change in bone microarchitecture

    Time frame: Baseline and 6 months

    Bone microarchitecture by high-resolution peripheral quantitative computed tomography

  5. Change in lipid profile

    Time frame: Baseline and 6 months

    Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 15, 2012
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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