Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-04 @ 10:43 PM
Study NCT ID:
NCT03042234
Status:
COMPLETED
Last Update Posted:
2021-07-15
First Post:
2017-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIT in Insulin-resistant and Insulin-sensitive Obese Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-11', 'studyFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of Peak oxygen consumption (VOpeak)', 'timeFrame': '4 weeks', 'description': 'The cardiopulmonary test protocol for determination the VOpeak (ml/kg/min) included running on a treadmill (Model ATL, Inbrasport Ltda; Brazil) at a speed of 4 km/h with 1 km/h increments every minute until the participant showed exhaustion.\n\nWe evaluated ventilatory parameters on a gas analyzer (model VO2000; Inbrasport Ltda; Brazil).'}, {'measure': 'rate of Intensity at first ventilatory anaerobic threshold (VAT1)', 'timeFrame': '4 weeks', 'description': 'The cardiopulmonary test protocol included running on a treadmill (Model ATL, Inbrasport Ltda; Brazil) at a speed of 4 km/h with 1 km/h increments every minute until the participant showed exhaustion.\n\nWe evaluated ventilatory parameters on a gas analyzer (model VO2000; Inbrasport Ltda; Brazil).We determined VAT1 (ml/kg/min) using the V-slope method of Beaver et al.'}, {'measure': 'rate of Peak Heart rate', 'timeFrame': '4 weeks', 'description': 'The cardiopulmonary test protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil). speed of 4 km / h with increments of 1 km / h every minute until the participant shows exhaustion.'}, {'measure': 'rate of carbohydrate oxidation', 'timeFrame': '4 weeks', 'description': 'The substrate oxidation pattern protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil),during continuous exercise of submaximal intensity (45 minutes of treadmill running at the intensity of the first ventilatory anaerobic threshold).'}, {'measure': 'rate of lipid oxidation', 'timeFrame': '4 weeks', 'description': 'The substrate oxidation pattern protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil),during continuous exercise of submaximal intensity (45 minutes of treadmill running at the intensity of the first ventilatory anaerobic threshold).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Insulin-resistant', 'Adolescents', 'High-intensity interval training'], 'conditions': ['Obesity', 'Insulin-resistant', 'Adolescents']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'ROSSETTI, MB; BRITO, RR; NORTON, RC. Prevenção primária de doenças cardiovasculares na obesidade infatojuvenil: efeito anti-inflamatório do exercício físico. Rev Bras Med Esporte. 2009'}, {'pmid': '22880097', 'type': 'BACKGROUND', 'citation': 'Corte de Araujo AC, Roschel H, Picanco AR, do Prado DM, Villares SM, de Sa Pinto AL, Gualano B. Similar health benefits of endurance and high-intensity interval training in obese children. PLoS One. 2012;7(8):e42747. doi: 10.1371/journal.pone.0042747. Epub 2012 Aug 6.'}, {'type': 'BACKGROUND', 'citation': 'KLOSTER, R & LIBERALI, R. Emagrecimento: composição da dieta e exercício físico. Rev Bras Nutr Esportiva. 2012 set-out; 11(2):288-306'}, {'type': 'BACKGROUND', 'citation': 'FOUREAUX, G; PINTO, KMC; DÂMASO, A. Efeito do consumo excessivo de oxigênio após exercício e da taxa metabólica de repouso no gasto energético. Rev Bras Med Esporte. 2006 nov-dez; 12(6):393-398.'}, {'type': 'BACKGROUND', 'citation': "AMERICAN COLLEGE OF SPORTS MEDICINE - ACSM. ACSM's Guidelines for Exercise Testing and Prescription. 8ª edição. Baltimore: Williams & Wilkins, 2009."}, {'pmid': '19002708', 'type': 'BACKGROUND', 'citation': 'Aucouturier J, Rance M, Meyer M, Isacco L, Thivel D, Fellmann N, Duclos M, Duche P. Determination of the maximal fat oxidation point in obese children and adolescents: validity of methods to assess maximal aerobic power. Eur J Appl Physiol. 2009 Jan;105(2):325-31. doi: 10.1007/s00421-008-0907-3. Epub 2008 Nov 12.'}, {'type': 'BACKGROUND', 'citation': 'MARQUEZI, ML. Adaptações decorrentes do exercício cardiorrespiratório sobre a oxidação de lipídeos: exercício aeróbio. Rev Mackenzie de Educação Física e Esporte. 2010; 9(1):32-35.'}, {'pmid': '11782653', 'type': 'BACKGROUND', 'citation': 'Achten J, Gleeson M, Jeukendrup AE. Determination of the exercise intensity that elicits maximal fat oxidation. 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Effects of insulin resistance on substrate utilization during exercise in overweight women. J Appl Physiol (1985). 2004 Sep;97(3):991-7. doi: 10.1152/japplphysiol.00231.2004. Epub 2004 May 7.'}, {'pmid': '11118013', 'type': 'BACKGROUND', 'citation': 'Blaak EE, van Aggel-Leijssen DP, Wagenmakers AJ, Saris WH, van Baak MA. Impaired oxidation of plasma-derived fatty acids in type 2 diabetic subjects during moderate-intensity exercise. Diabetes. 2000 Dec;49(12):2102-7. doi: 10.2337/diabetes.49.12.2102.'}, {'pmid': '12444908', 'type': 'BACKGROUND', 'citation': 'Borghouts LB, Wagenmakers AJ, Goyens PL, Keizer HA. Substrate utilization in non-obese Type II diabetic patients at rest and during exercise. Clin Sci (Lond). 2002 Dec;103(6):559-66. doi: 10.1042/cs1030559.'}, {'pmid': '11547220', 'type': 'BACKGROUND', 'citation': 'Perez-Martin A, Dumortier M, Raynaud E, Brun JF, Fedou C, Bringer J, Mercier J. Balance of substrate oxidation during submaximal exercise in lean and obese people. 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A mathematical model to describe fat oxidation kinetics during graded exercise. Med Sci Sports Exerc. 2009 Aug;41(8):1615-25. doi: 10.1249/MSS.0b013e31819e2f91.'}, {'pmid': '24523934', 'type': 'BACKGROUND', 'citation': 'Lanzi S, Codecasa F, Cornacchia M, Maestrini S, Salvadori A, Brunani A, Malatesta D. Fat oxidation, hormonal and plasma metabolite kinetics during a submaximal incremental test in lean and obese adults. PLoS One. 2014 Feb 11;9(2):e88707. doi: 10.1371/journal.pone.0088707. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the effects of HIT on the cardiorespiratory performance and substrate oxidation of insulin-resistant and insulin-sensitive obese adolescents.', 'detailedDescription': 'Objective: To evaluate the effect of high-intensity interval training (HIT) on the cardiorespiratory performance and substrate oxidation pattern in insulin-resistant and insulin-sensitive obese adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Criteria\n\nInclusion Criteria:\n\n* aged 12-16 years\n* with a body mass index z-score (zBMI) ≥ + 2SD\n* puberty stage \\> 3\n* the boys and girls had to present a minimum physical fitness, according to the International Physical Activity Questionnaire (IPAQ), according to the activity performed during the last week and confirmed this using the peak cardiopulmonary test (VO2).\n\nExclusion Criteria:\n\n* individuals undergoing drug treatment for weight control;\n* indiviudals who had cardiac, orthopedic, respiratory or renal problems, diabetes, uncontrolled hypertension, genetic syndrome or hormonal abnormalities.'}, 'identificationModule': {'nctId': 'NCT03042234', 'briefTitle': 'HIT in Insulin-resistant and Insulin-sensitive Obese Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}, 'officialTitle': 'Effects of High-intensity Interval Training on Cardiorespiratory Performance and Substrate Oxidation in Insulin-resistant and Insulin-sensitive Obese Adolescents: A Before-and-after Clinical Study', 'orgStudyIdInfo': {'id': 'japarecido'}, 'secondaryIdInfos': [{'id': '34634414.5.0000.5479', 'type': 'REGISTRY', 'domain': 'CAAE'}, {'id': '1.227.250', 'type': 'OTHER', 'domain': 'Number of opinion'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Insulin-resistant', 'description': 'Insulin-resistant obese adolescents', 'interventionNames': ['Other: Group Insulin-Resistant', 'Other: Group Insulin-Sensitive']}, {'type': 'EXPERIMENTAL', 'label': 'Group Insulin-sensitive', 'description': 'Insulin-sensitive obese adolescents', 'interventionNames': ['Other: Group Insulin-Resistant', 'Other: Group Insulin-Sensitive']}], 'interventions': [{'name': 'Group Insulin-Resistant', 'type': 'OTHER', 'otherNames': ['Insulin-resistant obese adolescents'], 'description': 'High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.', 'armGroupLabels': ['Group Insulin-resistant', 'Group Insulin-sensitive']}, {'name': 'Group Insulin-Sensitive', 'type': 'OTHER', 'otherNames': ['Insulin-sensitive obese adolescents'], 'description': 'High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.', 'armGroupLabels': ['Group Insulin-resistant', 'Group Insulin-sensitive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01221-020', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Santa Casa of Sao Paulo School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '02545-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Emef Angelina Maffei Vita', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '08341-080', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Emef Plinio Queroz', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Juliana Monique Lino Aparecido', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator Juliana Monique Lino Aparecido', 'investigatorFullName': 'JULIANA MONIQUE LINO', 'investigatorAffiliation': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}}}}