Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

Obesity Clinical Trial

Official title:

Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00456651
• Other study ID #: IB570/05
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2007
• Last updated: April 4, 2007
• Start date: February 2007

Study information

• Verified date: April 2007
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: Mónica de la Peña, MD
• Phone: 34 971 175112
• Email: mdelapena[@]hsd.es
• Is FDA regulated: No
• Health authority: Spain: Ministerio de Salud y Consumo
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Apnea
• Obesity
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• CPAP (Continuous Positive Airway Pressure)

Locations

Country	Name	City	State
Spain	Hospital Universitario Son Dureta	Palma de Mallorca	Baleares

Sponsors (3)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica	Fondo de Investigacion Sanitaria, Fundacion Caubet-Cimera Islas Baleares

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OBJECTIVES: To compare the plasmatic profiles of different hormones
Primary	and neuropeptides, related with weight control, metabolism and intake
Primary	in patients with SAHS as well as in selected control subjects according
Primary	to weight.
Secondary	CPAP (Continuous Positive Airway Pressure) effect on studied variables