Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

Sociedad Española de Neumología y Cirugía Torácica

Status: Unknown

Conditions: Obesity; Sleep Apnea

Treatments: Device: CPAP (Continuous Positive Airway Pressure)

Study type: Interventional

Funder types: Other

Identifiers

NCT00456651

IB570/05

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)