Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity
NCT ID: NCT00456651
Last Updated: 2007-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2007-02-28
Brief Summary
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The chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome (SAHS) may affect the central mechanisms that regulate nutritive behavior and energetic balance, causing an alteration in the secretion of hormones that favour the appearance and/or development of obesity.
Detailed Description
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DESIGN: Multicenter, prospective and controlled study. 40 patients with SAHS will be included as well as 40 control subjects.
METHODS: To all subjects included in the study, the following procedures will be performed:
1. Medical History;
2. Anthropometric variables (height, weight, Body Mass Index;
3. Somnolence evaluation using the Epworth scale;
4. Conventional Polysomnography (PSG);
5. Determination every four hours during a 24 hours period of the levels of leptin adiponectin, resistin, insulin, PCR, etc.
6. Conventional biologic evaluation;
7. Patients will be re-evaluated after three months of treatment with CPAP.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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CPAP (Continuous Positive Airway Pressure)
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index \< 27 or \> 30 Kg/m2
Exclusion Criteria
* Drug addiction and/or alcoholism
* Refusal to sign informed consent
25 Years
65 Years
MALE
No
Sponsors
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Fundacion Caubet-Cimera Islas Baleares
OTHER
Fondo de Investigacion Sanitaria
OTHER
Sociedad Española de Neumología y Cirugía Torácica
OTHER
Principal Investigators
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Mónica de la Peña, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Son Dureta
Locations
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Hospital Universitario Son Dureta
Palma de Mallorca, Balearic Islands, Spain
Countries
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Central Contacts
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Other Identifiers
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IB570/05
Identifier Type: -
Identifier Source: org_study_id