Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

Not Applicable

• Conditions: Sleep Apnea; Obesity

• Registration Number: NCT00456651
• Lead Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Brief Summary

The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have different pattern in the secretion of hormones.

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

OBJECTIVES: To compare the plasmatic profiles of different hormones and neuropeptides, related with weight control, metabolism and intake in patients with SAHS as well as in selected control subjects according to weight.

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.

Study Timeline

• Study Start: 2007-02
• Status Verified: 2007-04
• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-04
• Last Update Submitted: 2007-04-04
• Study First Posted: 2007-04-05
• Last Update Posted: 2007-04-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Apnea-Hypopnea Index > 15
• Body Mass Index < 27 or > 30 Kg/m2

Exclusion Criteria

• Presence of any chronic disease
• Drug addiction and/or alcoholism
• Refusal to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
OBJECTIVES: To compare the plasmatic profiles of different hormones
and neuropeptides, related with weight control, metabolism and intake
in patients with SAHS as well as in selected control subjects according
to weight.

Secondary Outcome Measures

Name	Time	Method
CPAP (Continuous Positive Airway Pressure) effect on studied variables

Trial Locations

Locations (1)

Hospital Universitario Son Dureta; 🇪🇸 Palma de Mallorca, Baleares, Spain