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Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Sociedad Española de Neumología y Cirugía Torácica.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00456651
First Posted: April 5, 2007
Last Update Posted: April 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fundacion Caubet-Cimera Islas Baleares
Fondo de Investigacion Sanitaria
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica
  Purpose

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.


Condition Intervention
Sleep Apnea Obesity Device: CPAP (Continuous Positive Airway Pressure)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

Resource links provided by NLM:


Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

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

Estimated Enrollment: 40
Study Start Date: February 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456651


Contacts
Contact: Mónica de la Peña, MD 34 971 175112 mdelapena@hsd.es

Locations
Spain
Hospital Universitario Son Dureta Recruiting
Palma de Mallorca, Baleares, Spain, 07001
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Fundacion Caubet-Cimera Islas Baleares
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Mónica de la Peña, MD Hospital Universitario Son Dureta
  More Information

ClinicalTrials.gov Identifier: NCT00456651     History of Changes
Other Study ID Numbers: IB570/05
First Submitted: April 4, 2007
First Posted: April 5, 2007
Last Update Posted: April 5, 2007
Last Verified: April 2007

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
Sleep Apnea
Obesity
Neuropeptides
Hormones

Additional relevant MeSH terms:
Obesity
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases