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Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

Primary Purpose

Sleep Apnea, Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

CPAP (Continuous Positive Airway Pressure)

About this trial

This is an interventional prevention trial for Sleep Apnea focused on measuring Sleep Apnea, Obesity, Neuropeptides, Hormones

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Hospital Universitario Son DuretaRecruiting

Outcomes

Primary Outcome Measures

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

CPAP (Continuous Positive Airway Pressure) effect on studied variables

Full Information

NCT ID

NCT00456651

First Posted

April 4, 2007

Last Updated

April 4, 2007

Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Collaborators

Fundacion Caubet-Cimera Islas Baleares, Fondo de Investigacion Sanitaria

1. Study Identification

Unique Protocol Identification Number

NCT00456651

Brief Title

Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

Official Title

Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Unknown status

Study Start Date

February 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Collaborators

Fundacion Caubet-Cimera Islas Baleares, Fondo de Investigacion Sanitaria

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: Medical History; Anthropometric variables (height, weight, Body Mass Index; Somnolence evaluation using the Epworth scale; Conventional Polysomnography (PSG); Determination every four hours during a 24 hours period of the levels of leptin adiponectin, resistin, insulin, PCR, etc. Conventional biologic evaluation; Patients will be re-evaluated after three months of treatment with CPAP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea, Obesity

Keywords

Sleep Apnea, Obesity, Neuropeptides, Hormones

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

CPAP (Continuous Positive Airway Pressure)

Primary Outcome Measure Information:

Title

OBJECTIVES: To compare the plasmatic profiles of different hormones

Title

and neuropeptides, related with weight control, metabolism and intake

Title

in patients with SAHS as well as in selected control subjects according

Title

to weight.

Secondary Outcome Measure Information:

Title

CPAP (Continuous Positive Airway Pressure) effect on studied variables

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mónica de la Peña, MD

Phone

34 971 175112

mdelapena@hsd.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mónica de la Peña, MD

Organizational Affiliation

Hospital Universitario Son Dureta

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario Son Dureta

City

Palma de Mallorca

State/Province

Baleares

ZIP/Postal Code

07001

Country

Spain

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

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