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Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Sociedad Española de Neumología y Cirugía Torácica.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Fundacion Caubet-Cimera Islas Baleares
Fondo de Investigacion Sanitaria
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT00456651
First received: April 4, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

Resource links provided by NLM:

MedlinePlus related topics: Obesity Sleep Apnea
U.S. FDA Resources

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

Ages Eligible for Study:   25 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00456651     History of Changes
Other Study ID Numbers: IB570/05
Study First Received: April 4, 2007
Last Updated: April 4, 2007
Health Authority: Spain: Ministerio de Salud y Consumo

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

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

ClinicalTrials.gov processed this record on May 19, 2013