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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-04-04', 'studyFirstSubmitDate': '2007-04-04', 'studyFirstSubmitQcDate': '2007-04-04', 'lastUpdatePostDateStruct': {'date': '2007-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OBJECTIVES: To compare the plasmatic profiles of different hormones'}, {'measure': 'and neuropeptides, related with weight control, metabolism and intake'}, {'measure': 'in patients with SAHS as well as in selected control subjects according'}, {'measure': 'to weight.'}], 'secondaryOutcomes': [{'measure': 'CPAP (Continuous Positive Airway Pressure) effect on studied variables'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep Apnea', 'Obesity', 'Neuropeptides', 'Hormones'], 'conditions': ['Sleep Apnea', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have different pattern in the secretion of hormones.\n\nThe 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.', 'detailedDescription': '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.\n\nDESIGN: Multicenter, prospective and controlled study. 40 patients with SAHS will be included as well as 40 control subjects.\n\nMETHODS: To all subjects included in the study, the following procedures will be performed:\n\n1. Medical History;\n2. Anthropometric variables (height, weight, Body Mass Index;\n3. Somnolence evaluation using the Epworth scale;\n4. Conventional Polysomnography (PSG);\n5. Determination every four hours during a 24 hours period of the levels of leptin adiponectin, resistin, insulin, PCR, etc.\n6. Conventional biologic evaluation;\n7. Patients will be re-evaluated after three months of treatment with CPAP.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apnea-Hypopnea Index \\> 15\n* Body Mass Index \\< 27 or \\> 30 Kg/m2\n\nExclusion Criteria:\n\n* Presence of any chronic disease\n* Drug addiction and/or alcoholism\n* Refusal to sign informed consent'}, 'identificationModule': {'nctId': 'NCT00456651', 'briefTitle': 'Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Sociedad Española de Neumología y Cirugía Torácica'}, 'officialTitle': 'Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity', 'orgStudyIdInfo': {'id': 'IB570/05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CPAP (Continuous Positive Airway Pressure)', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07001', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Son Dureta', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}], 'centralContacts': [{'name': 'Mónica de la Peña, MD', 'role': 'CONTACT', 'email': 'mdelapena@hsd.es', 'phone': '34 971 175112'}], 'overallOfficials': [{'name': 'Mónica de la Peña, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Son Dureta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sociedad Española de Neumología y Cirugía Torácica', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundacion Caubet-Cimera Islas Baleares', 'class': 'OTHER'}, {'name': 'Fondo de Investigacion Sanitaria', 'class': 'OTHER'}]}}}