Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-28 @ 10:07 AM
Study NCT ID:
NCT01512368
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2012-01-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels Correlated With Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shiverqks@hotmail.com', 'phone': '525554870900', 'title': 'Dr. Daniel Cuevas-Ramos', 'phoneExt': '2407', 'organization': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We cannot fully control other potential sources of physical activity. The results may not be applicable to men. We did not register the caloric consumption during the study.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were supervised throughout every treadmill test.', 'description': 'Continuous electrocardiographic monitoring were registered in every treadmill test.', 'eventGroups': [{'id': 'EG000', 'title': 'Supervised Exercising', 'description': "A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.", 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supervised Exercising', 'description': "A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '276.8', 'groupId': 'OG000', 'lowerLimit': '142.8', 'upperLimit': '568.6'}]}]}, {'title': 'Final (after 2 weeks)', 'categories': [{'measurements': [{'value': '460.8', 'groupId': 'OG000', 'lowerLimit': '298.2', 'upperLimit': '742.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.089', 'ciLowerLimit': '0.034', 'ciUpperLimit': '0.144', 'pValueComment': 'All reported p values are based on two-sided tests considering ≤0.05 as significant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.063', 'estimateComment': 'Metabolic equivalents (METs) consumed were independently associated with the log of delta (final-basal) FGF21 levels.', 'groupDescription': '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").', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for age, time of exercise, creatinine, waist to hip ratio, fat percentage, body mass index, mean rest heart rate, blood pressure.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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.', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supervised Exercising', 'description': "A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '0.44'}]}]}, {'title': 'Final (after 2 weeks)', 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '0.66'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Epinephrine Acutely and at Two Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supervised Exercising', 'description': "A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '12.1'}]}]}, {'title': 'Final (at 2 weeks)', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '18.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Leptin Acutely and at Two Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supervised Exercising', 'description': "A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '21.1'}]}]}, {'title': 'Final (at 2 weeks)', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '16.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Total Adiponectin Acutely and at Two Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supervised Exercising', 'description': "A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '13.4'}]}]}, {'title': 'Final (at 2 weeks)', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '13.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Fasting Glucose Acutely and at Two Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supervised Exercising', 'description': "A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants."}], 'classes': [{'title': 'Baseline Glucose', 'categories': [{'measurements': [{'value': '86.0', 'spread': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Final Glucose (at 2 weeks)', 'categories': [{'measurements': [{'value': '86.3', 'spread': '6.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Supervised Exercising', 'description': "A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Supervised Exercising', 'description': "A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '3.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-09', 'studyFirstSubmitDate': '2012-01-11', 'resultsFirstSubmitDate': '2012-01-20', 'studyFirstSubmitQcDate': '2012-01-13', 'lastUpdatePostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-23', 'studyFirstPostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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.'}, {'measure': 'Change From Baseline Epinephrine Acutely and at Two Weeks', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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.'}, {'measure': 'Change From Baseline Leptin Acutely and at Two Weeks', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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'}, {'measure': 'Change From Baseline Total Adiponectin Acutely and at Two Weeks', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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'}, {'measure': 'Change From Baseline Fasting Glucose Acutely and at Two Weeks', 'timeFrame': 'Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fibroblast growth factor 21 (FGF21)', 'Exercise', 'Metabolic equivalents (METs)', 'Lipolysis', 'Glucose', 'Free fatty acids (FFAs)', 'Epinephrine'], 'conditions': ['Sedentary Lifestyle']}, 'referencesModule': {'references': [{'pmid': '20566587', 'type': 'BACKGROUND', 'citation': 'Cuevas-Ramos D, Almeda-Valdes P, Gomez-Perez FJ, Meza-Arana CE, Cruz-Bautista I, Arellano-Campos O, Navarrete-Lopez 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.'}, {'pmid': '11991917', 'type': 'BACKGROUND', 'citation': 'Hill J, Timmis A. Exercise tolerance testing. BMJ. 2002 May 4;324(7345):1084-7. doi: 10.1136/bmj.324.7345.1084. No abstract available.'}, {'pmid': '22701542', 'type': 'DERIVED', 'citation': 'Cuevas-Ramos D, Almeda-Valdes P, Meza-Arana CE, Brito-Cordova G, Gomez-Perez 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.'}], 'seeAlsoLinks': [{'url': 'http://www.innsz.mx', 'label': 'INCMNSZ'}]}, '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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* Aged 18 to 35 years old,\n* Body mass index (BMI) \\<30 kg/m2\n* Without contraindication for exercising\n\nExclusion Criteria:\n\n* Metabolic syndrome\n* Diabetes\n* Dyslipidemia\n* Hypertension\n* Asthma\n* Thyroid disease\n* Treated with fibrates, beta agonists or blockers\n* History or current arrhythmias, murmurs, cardiomegaly, or treatment for cardiovascular diseases -\n* Contraindications for exercise testing were also considered as exclusion criteria (see references)'}, 'identificationModule': {'nctId': 'NCT01512368', 'briefTitle': 'Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels Correlated With Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels After a Cardiorespiratory Exercise Program', 'orgStudyIdInfo': {'id': 'REF173'}, 'secondaryIdInfos': [{'id': '48024', 'type': 'OTHER_GRANT', 'domain': 'Consejo Nacional de Ciencia y Tecnología (CONACYT)/216324'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supervised exercising', 'description': "A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.", 'interventionNames': ['Other: Supervised Exercising']}], 'interventions': [{'name': 'Supervised Exercising', 'type': 'OTHER', 'otherNames': ["Bruce's protocol"], 'description': "A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks.", 'armGroupLabels': ['Supervised exercising']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Mexico City', 'state': 'Tlalpan', 'country': 'Mexico', 'facility': 'INCMNSZ', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Daniel Cuevas-Ramos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, {'name': 'Paloma Almeda-Valdes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, {'name': 'Carlos A Aguilar-Salinas, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Daniel Cuevas-Ramos', 'investigatorAffiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}}}}