Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT01985035
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2013-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-01', 'studyFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2013-11-14', 'lastUpdatePostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy expenditure', 'timeFrame': 'up to 4 months', 'description': 'Measurements of energy expenditure by doubly labeled water for day energy expenditure and by calorimetry for resting energy expenditure and thermic effect of food'}], 'secondaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': 'Baseline, 1 month, 2 months and 4 months', 'description': 'Bodu composition evaluation by pletismografy to determine fat mass and fat free mass'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obstructive sleep apnea', 'obesity', 'diet', 'energy expenditure'], 'conditions': ['Obstructive Sleep Apnea', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '33745625', 'type': 'DERIVED', 'citation': 'de Melo CM, Dos Santos Quaresma MVL, Del Re MP, Ribeiro SML, Moreira Antunes HK, Togeiro SM, Tufik S, de Mello MT. One-month of a low-energy diet, with no additional effect of high-protein, reduces Obstructive Sleep Apnea severity and improve metabolic parameters in obese males. Clin Nutr ESPEN. 2021 Apr;42:82-89. doi: 10.1016/j.clnesp.2020.12.028. Epub 2021 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body composition and energy expenditure. The objective of this study is to evaluate the influence of OSA in energy metabolism and body mass loss in obese subjects. Ninety obese volunteers of both genders, 45 diagnosed with OSA and 45 without OSA, will be submitted to a dietary intervention of one months. Volunteers will be distributed into four groups: obese OSA PTN with moderate protein diet (1.6 g / kg protein / day), obese OSA CHO diet (0.8 g / kg protein / day) with standard composition diet, obese NSAOS PTN diet moderate in protein and CHO NSAOS obese standard diet. All groups will be instructed to perform a restricted energy diet (less 30% of daily energy expenditure). At baseline and one month after the beginning of the program the following evaluations will be conducted: total energy expenditure measured by doubly labeled water method, resting energy expenditure and thermic effect of food by calorimetry, polysomnography analysis, body composition by pletysmography, food consumption by three days of food diary, blood collection for analysis of lipid profile, visceral proteins, hormones related to control of body weight and inflammation. As hypothesis we believe that apneic obese individuals have greater difficult in weight loss and loss more free fat mass than the obese no apneic and that diets with more protein can contribute to greater weight loss, better body composition and energy expenditure in these population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index between 30 and 40 kg/m2;\n* Obstructive sleep apnea mild or severe;\n* Sedentary.\n\nExclusion Criteria:\n\n* Intake of any drug that interfere on metabolism such for thyroid or to lose weight;\n* Be engaged in other treatment for sleep apnea or obesity;\n* Present another sleep disorder;\n* Being shift work;\n* Present any kind of kidney disease.'}, 'identificationModule': {'nctId': 'NCT01985035', 'briefTitle': 'Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals', 'orgStudyIdInfo': {'id': 'RMR-PRO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obese Apneic carbohydrate diet', 'description': 'Obese apneic individuals will be subject to a energy restriction diet rich in carbohydrates', 'interventionNames': ['Behavioral: Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Obese Apneic protein diet', 'description': 'Obese apneic individuals will be subject to a energy restricted diet rich in protein', 'interventionNames': ['Behavioral: Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Obese Non Apneic carbohydrate diet', 'description': 'Obese individuals without Obstructive sleep apnea will be subjected to a energy restricted diet rich in carbohydrates', 'interventionNames': ['Behavioral: Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Obese Non Apneic protein diet', 'description': 'Obese individuals without Obstructive Sleep Apnea will be subjected to a energy restricted diet rich in protein', 'interventionNames': ['Behavioral: Diet']}], 'interventions': [{'name': 'Diet', 'type': 'BEHAVIORAL', 'otherNames': ['Energy restriction'], 'description': 'Reduction of energy intake in order to weight loss', 'armGroupLabels': ['Obese Apneic carbohydrate diet', 'Obese Apneic protein diet', 'Obese Non Apneic carbohydrate diet', 'Obese Non Apneic protein diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04023-062', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Departamento de Psicobiologia - Universidade Federal de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04024-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Federal de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Msc', 'investigatorFullName': 'Camila Maria de Melo', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}