{ "FullStudy":{ "Rank":218128, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512368", "OrgStudyIdInfo":{ "OrgStudyId":"REF173" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"48024", "SecondaryIdType":"Other Grant/Funding Number", "SecondaryIdDomain":"Consejo Nacional de Ciencia y Tecnología (CONACYT)/216324" } ] }, "Organization":{ "OrgFullName":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran", "OrgClass":"OTHER" }, "BriefTitle":"Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels Correlated With Exercise", "OfficialTitle":"Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels After a Cardiorespiratory Exercise Program" }, "StatusModule":{ "StatusVerifiedDate":"January 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 20, 2012", "ResultsFirstSubmitQCDate":"February 23, 2012", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 26, 2012", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 9, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 14, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Daniel Cuevas-Ramos", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran" }, "LeadSponsor":{ "LeadSponsorName":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"We evaluated the effect of two weeks of intensive supervised physical activity in serum fibroblast growth factor 21 (FGF21) levels.", "DetailedDescription":"Comparative and longitudinal study. Anthropometric and biochemical evaluation were done before, 1hr and 4hr after a bout of exercise and repeated after two weeks of daily supervised exercise. We studied sedentary young healthy women. A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks. The Department of Endocrinology and Metabolism at the INCMNSZ performed all biochemical laboratory measurements using standardized procedures." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Sedentary Lifestyle" ] }, "KeywordList":{ "Keyword":[ "Fibroblast growth factor 21 (FGF21)", "Exercise", "Metabolic equivalents (METs)", "Lipolysis", "Glucose", "Free fatty acids (FFAs)", "Epinephrine" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"82", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Supervised exercising", "ArmGroupType":"Experimental", "ArmGroupDescription":"A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Supervised Exercising" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"Supervised Exercising", "InterventionDescription":"A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Supervised exercising" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Bruce's protocol" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks", "PrimaryOutcomeDescription":"Serum measurement of FGF21 using human ELISA kit was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.", "PrimaryOutcomeTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks", "SecondaryOutcomeDescription":"Serum measurement of free fatty acids (FFAs) was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.", "SecondaryOutcomeTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise" },{ "SecondaryOutcomeMeasure":"Change From Baseline Epinephrine Acutely and at Two Weeks", "SecondaryOutcomeDescription":"Serum measurement of epinephrine was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.", "SecondaryOutcomeTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise" },{ "SecondaryOutcomeMeasure":"Change From Baseline Leptin Acutely and at Two Weeks", "SecondaryOutcomeDescription":"Serum measurement of leptin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "SecondaryOutcomeTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise" },{ "SecondaryOutcomeMeasure":"Change From Baseline Total Adiponectin Acutely and at Two Weeks", "SecondaryOutcomeDescription":"Serum measurement of total adiponectin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "SecondaryOutcomeTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise" },{ "SecondaryOutcomeMeasure":"Change From Baseline Fasting Glucose Acutely and at Two Weeks", "SecondaryOutcomeDescription":"Serum measurement of glucose was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "SecondaryOutcomeTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nWomen\nAged 18 to 35 years old,\nBody mass index (BMI) <30 kg/m2\nWithout contraindication for exercising\n\nExclusion Criteria:\n\nMetabolic syndrome\nDiabetes\nDyslipidemia\nHypertension\nAsthma\nThyroid disease\nTreated with fibrates, beta agonists or blockers\nHistory or current arrhythmias, murmurs, cardiomegaly, or treatment for cardiovascular diseases -\nContraindications for exercise testing were also considered as exclusion criteria (see references)", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"Female", "MinimumAge":"18 Years", "MaximumAge":"35 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Daniel Cuevas-Ramos, MD", "OverallOfficialAffiliation":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Paloma Almeda-Valdes, MD", "OverallOfficialAffiliation":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Carlos A Aguilar-Salinas, MD", "OverallOfficialAffiliation":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"INCMNSZ", "LocationCity":"Mexico City", "LocationState":"Tlalpan", "LocationZip":"14000", "LocationCountry":"Mexico" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"20566587", "ReferenceType":"background", "ReferenceCitation":"Cuevas-Ramos D, Almeda-Valdes P, Gómez-Pérez FJ, Meza-Arana CE, Cruz-Bautista I, Arellano-Campos O, Navarrete-López M, Aguilar-Salinas CA. Daily physical activity, fasting glucose, uric acid, and body mass index are independent factors associated with serum fibroblast growth factor 21 levels. Eur J Endocrinol. 2010 Sep;163(3):469-77. doi: 10.1530/EJE-10-0454. Epub 2010 Jun 21." },{ "ReferencePMID":"11991917", "ReferenceType":"background", "ReferenceCitation":"Hill J, Timmis A. Exercise tolerance testing. BMJ. 2002 May 4;324(7345):1084-7. Review." },{ "ReferencePMID":"22701542", "ReferenceType":"derived", "ReferenceCitation":"Cuevas-Ramos D, Almeda-Valdés P, Meza-Arana CE, Brito-Córdova G, Gómez-Pérez FJ, Mehta R, Oseguera-Moguel J, Aguilar-Salinas CA. Exercise increases serum fibroblast growth factor 21 (FGF21) levels. PLoS One. 2012;7(5):e38022. doi: 10.1371/journal.pone.0038022. Epub 2012 May 31." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"INCMNSZ", "SeeAlsoLinkURL":"http://www.innsz.mx" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"In the initial visit, patients were instructed to keep unaltered their diet, lifestyle and physical activity. Basal daily physical activity was evaluated with a questionnaire. All participants were assigned to the intervention group. All subjects underwent basal and final physical and biochemical evaluation.", "FlowRecruitmentDetails":"From March 2010 to August 2011 a total of 60 sedentary young women without contraindication for exercising were included. Study was carried out at Department of Endocrinology, Cardiology and Internal Medicine of the INCMNSZ.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Supervised Exercising", "FlowGroupDescription":"A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"63" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"60" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Supervised Exercising", "BaselineGroupDescription":"A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"63" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"63" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"24.0", "BaselineMeasurementSpread":"3.7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"63" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Mexico", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"63" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks", "OutcomeMeasureDescription":"Serum measurement of FGF21 using human ELISA kit was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.", "OutcomeMeasurePopulationDescription":"The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated. All participants were analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"ng/L", "OutcomeMeasureTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Supervised Exercising", "OutcomeGroupDescription":"A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"276.8", "OutcomeMeasurementLowerLimit":"142.8", "OutcomeMeasurementUpperLimit":"568.6" } ] } } ] } },{ "OutcomeClassTitle":"Final (after 2 weeks)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"460.8", "OutcomeMeasurementLowerLimit":"298.2", "OutcomeMeasurementUpperLimit":"742.1" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"FGF21 was log transformed to approximate normality before analyses. Null hypothesis was Ho = Y1 (FGF21 level at baseline) = Y2 (FGF21 level after two weeks of exercising). Power calculation was 80% with 60 participants evaluated (one group). To evaluate the effect of exercise on clinical and biochemical parameters, we used the difference between final – basal levels (“delta”).", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisPValueComment":"All reported p values are based on two-sided tests considering ≤0.05 as significant.", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisStatisticalComment":"Adjusted for age, time of exercise, creatinine, waist to hip ratio, fat percentage, body mass index, mean rest heart rate, blood pressure.", "OutcomeAnalysisParamType":"Slope", "OutcomeAnalysisParamValue":"0.089", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.034", "OutcomeAnalysisCIUpperLimit":"0.144", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"0.063", "OutcomeAnalysisEstimateComment":"Metabolic equivalents (METs) consumed were independently associated with the log of delta (final-basal) FGF21 levels." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks", "OutcomeMeasureDescription":"Serum measurement of free fatty acids (FFAs) was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.", "OutcomeMeasurePopulationDescription":"The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"mg/dL", "OutcomeMeasureTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Supervised Exercising", "OutcomeGroupDescription":"A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.36", "OutcomeMeasurementLowerLimit":"0.24", "OutcomeMeasurementUpperLimit":"0.44" } ] } } ] } },{ "OutcomeClassTitle":"Final (after 2 weeks)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.54", "OutcomeMeasurementLowerLimit":"0.43", "OutcomeMeasurementUpperLimit":"0.66" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline Epinephrine Acutely and at Two Weeks", "OutcomeMeasureDescription":"Serum measurement of epinephrine was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.", "OutcomeMeasurePopulationDescription":"The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report (5), we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"pg/mL", "OutcomeMeasureTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Supervised Exercising", "OutcomeGroupDescription":"A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9.2", "OutcomeMeasurementLowerLimit":"5.9", "OutcomeMeasurementUpperLimit":"12.1" } ] } } ] } },{ "OutcomeClassTitle":"Final (at 2 weeks)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.5", "OutcomeMeasurementLowerLimit":"11.3", "OutcomeMeasurementUpperLimit":"18.8" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline Leptin Acutely and at Two Weeks", "OutcomeMeasureDescription":"Serum measurement of leptin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "OutcomeMeasurePopulationDescription":"The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"ng/mL", "OutcomeMeasureTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Supervised Exercising", "OutcomeGroupDescription":"A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13.1", "OutcomeMeasurementLowerLimit":"8.7", "OutcomeMeasurementUpperLimit":"21.1" } ] } } ] } },{ "OutcomeClassTitle":"Final (at 2 weeks)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12.4", "OutcomeMeasurementLowerLimit":"10.0", "OutcomeMeasurementUpperLimit":"16.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline Total Adiponectin Acutely and at Two Weeks", "OutcomeMeasureDescription":"Serum measurement of total adiponectin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "OutcomeMeasurePopulationDescription":"The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"ng/mL", "OutcomeMeasureTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Supervised Exercising", "OutcomeGroupDescription":"A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.1", "OutcomeMeasurementLowerLimit":"8.0", "OutcomeMeasurementUpperLimit":"13.4" } ] } } ] } },{ "OutcomeClassTitle":"Final (at 2 weeks)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.5", "OutcomeMeasurementLowerLimit":"8.0", "OutcomeMeasurementUpperLimit":"13.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline Fasting Glucose Acutely and at Two Weeks", "OutcomeMeasureDescription":"Serum measurement of glucose was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "OutcomeMeasurePopulationDescription":"The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mg/dL", "OutcomeMeasureTimeFrame":"Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Supervised Exercising", "OutcomeGroupDescription":"A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline Glucose", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"86.0", "OutcomeMeasurementSpread":"7.1" } ] } } ] } },{ "OutcomeClassTitle":"Final Glucose (at 2 weeks)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"86.3", "OutcomeMeasurementSpread":"6.4" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"Adverse events were supervised throughout every treadmill test.", "EventsDescription":"Continuous electrocardiographic monitoring were registered in every treadmill test.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Supervised Exercising", "EventGroupDescription":"A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"60", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"60" } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Dr. Daniel Cuevas-Ramos", "PointOfContactOrganization":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran", "PointOfContactEMail":"shiverqks@hotmail.com", "PointOfContactPhone":"525554870900", "PointOfContactPhoneExt":"2407" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" } } } } }