Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-29 @ 7:44 PM
Study NCT ID:
NCT00456651
Status:
UNKNOWN
Last Update Posted:
2007-04-05
First Post:
2007-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity
Sponsor:
Sociedad Española de Neumología y Cirugía Torácica
Organization:
Study Overview
Official Title:
Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: