Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT04417218
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2020-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008239', 'term': 'Lysine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jane.f.ferguson@vumc.org', 'phone': '6158759896', 'title': 'Dr. Jane Ferguson', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected over the 4 week study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Lysine Diet', 'description': 'Participants will complete two one-week dietary interventions, in a randomized order. For the normal lysine diet, participants will be asked to adhere to a specific diet for 1 week. Each study subject will receive 3 meals and 1-2 snacks per day during the study period.\n\nControlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 2, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Lysine Diet', 'description': 'Participants will complete two one-week dietary interventions, in a randomized order. For the high lysine diet, participants will be asked to consume the same foods as in the normal lysine diet, but with the addition of lysine supplements (5g/day).\n\nLysine: Lysine is an essential amino acid which is acquired from dietary sources.\n\nControlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 7, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bloating', 'notes': 'Reports of bloating, gas, or GI discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Changes in mood', 'notes': 'reported improvement in mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in mood', 'notes': 'reported nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'notes': 'Reported pain and bruising following blood draw.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Plasma 2-AAA Concentration From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Lysine Diet', 'description': 'Participants will complete two one-week dietary interventions, in a randomized order. For the normal lysine diet, participants will be asked to adhere to a specific diet for 1 week. Each study subject will receive 3 meals and 1-2 snacks per day during the study period.\n\nControlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.'}, {'id': 'OG001', 'title': 'High Lysine Diet', 'description': 'Participants will complete two one-week dietary interventions, in a randomized order. For the high lysine diet, participants will be asked to consume the same foods as in the normal lysine diet, but with the addition of lysine supplements (5g/day).\n\nLysine: Lysine is an essential amino acid which is acquired from dietary sources.\n\nControlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.35', 'spread': '30.3', 'groupId': 'OG000'}, {'value': '7.02', 'spread': '23.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from pre-diet to post-diet (1 week)', 'description': 'Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as post-diet minus pre-diet for each Intervention (Normal lysine and High lysine).', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals were included for analysis only if they had provided a blood sample for measurement of 2-AAA at both the pre- and post-diet timepoints. This excluded 3 individuals from the normal lysine diet intervention, and 4 individuals from the high lysine diet intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Lysine Diet First Then High Lysine Diet', 'description': 'Participants completed two one-week dietary interventions, in a randomized order, separated by a 2-week washout.\n\nFor the Normal Lysine diet, participants were asked to adhere to a specific diet for 1 week. Individuals were instructed to consume specific foods, to adhere to a controlled lysine diet. This comprised 3 meals and 1-2 snacks per day during the study period.\n\nFor the Washout, individuals were asked to resume their habitual diet for 2 weeks.\n\nFor the High Lysine diet, participants were asked to adhere to a specific diet for 1 week. Individuals were instructed to consume the same specific foods, as the Normal Lysine diet. This comprised 3 meals and 1-2 snacks per day during the study period. Participants were also instructed to take Lysine supplements with their meals (5g/day).\n\nLysine: Lysine is an essential amino acid which is acquired from dietary sources.\n\nControlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.'}, {'id': 'FG001', 'title': 'High Lysine Diet First Then Normal Lysine Diet', 'description': 'Participants completed two one-week dietary interventions, in a randomized order, separated by a 2-week washout.\n\nFor the High Lysine diet, participants were asked to adhere to a specific diet for 1 week. Individuals were instructed to consume specific foods. This comprised 3 meals and 1-2 snacks per day during the study period. Participants were also instructed to take Lysine supplements with their meals (5g/day).\n\nFor the Washout, individuals were asked to resume their habitual diet for 2 weeks.\n\nFor the Normal Lysine diet, participants were asked to adhere to a specific diet for 1 week. Individuals were instructed to consume specific foods (the same as during the High Lysine diet), to adhere to a controlled lysine diet. This comprised 3 meals and 1-2 snacks per day during the study period.\n\nLysine: Lysine is an essential amino acid which is acquired from dietary sources.\n\nControlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.'}], 'periods': [{'title': 'First Intervention (1 Week))', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'N=20 enrolled individuals withdrew or were lost to follow up prior to starting the intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dietary Intervention', 'description': 'Participants will complete two one-week dietary interventions, in a randomized order. For the normal lysine diet, participants will be asked to adhere to a specific diet for 1 week. Each study subject will receive 3 meals and 1-2 snacks per day during the study period.\n\nControlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.\n\nFor the high lysine diet, participants will be asked to consume the same foods as in the normal lysine diet, but with the addition of lysine supplements (5g/day).\n\nLysine: Lysine is an essential amino acid which is acquired from dietary sources.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-13', 'size': 1179659, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-28T13:31', 'hasProtocol': True}, {'date': '2022-03-03', 'size': 420350, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-16T21:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2020-06-02', 'resultsFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2020-06-02', 'lastUpdatePostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-20', 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Plasma 2-AAA Concentration From Baseline', 'timeFrame': 'Change from pre-diet to post-diet (1 week)', 'description': 'Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as post-diet minus pre-diet for each Intervention (Normal lysine and High lysine).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid (2-AAA).', 'detailedDescription': 'Diabetes is an important health concern worldwide. It is associated with significantly increased mortality as well as high incidence of co-morbidities. Unfortunately, treatment efficacy and successful disease management is highly variable among treated patients, and this is partly due to the fact that diabetes has multiple underlying causes most of which are still unknown. A newly identified biomarker, α-aminoadipic acid (2-AAA), has the potential to successfully predict the development of diabetes in humans, even before the development of other known risk markers. However, little is known about the function of 2-AAA; it is unclear whether 2-AAA itself causes the development of diabetes or if it is a biomarker for altered metabolic processes that then lead to diabetes.\n\nThe aim of the first phase of the study was to measure plasma 2-AAA levels from healthy individuals from the general population to identify subjects with high or low 2-AAA. Now in the second phase of the study, 80 subjects with high or low 2-AAA will be invited to participate in a dietary lysine modification study to access the effect of controlled lysine intake on plasma and urine 2AAA. Participants will be asked to complete two one-week dietary interventions. Subjects will be screened and consented via email, online, or phone. Each subject will be required to come to Vanderbilt University Medical Center for four study visits, at which the study team will obtain a blood sample, a urine sample, stool sample, vital signs, waist and hip circumference, and 1-3 surveys will be completed if the subject did not complete them prior to the visit. Each subject that completes the entire study visit will be compensated $250. DNA samples will be obtained to allow for identification of genetic predictors of 2-AAA levels. Some individuals may be asked to return for a future follow-up study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior participant in 2-AAA screening study.\n* Identified as eligible due to high or low plasma 2-AAA, in the absence of hyperglycemia, as defined by study team.\n\nExclusion Criteria:\n\n* Individuals who currently use tobacco products.\n* Use of prescription or over-the-counter medications or dietary supplements which could modulate levels of 2-AAA and unwilling to discontinue use (from 24 hours prior to first study visit until completion of study). Hormonal birth control is acceptable.\n* Follow a severely restricted diet or have food allergies, which would preclude adherence to study diet.\n* Newly diagnosed disease (since screening visit), including cardiovascular, renal, or liver disease, or Diabetes mellitus.\n* Individuals who are pregnant or lactating\n* Inability to provide written or electronic informed consent\n* Inability to fast for 8 hours'}, 'identificationModule': {'nctId': 'NCT04417218', 'briefTitle': 'Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2', 'orgStudyIdInfo': {'id': '200427'}, 'secondaryIdInfos': [{'id': 'R01DK117144', 'link': 'https://reporter.nih.gov/quickSearch/R01DK117144', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal Lysine Diet', 'description': 'Participants will complete two one-week dietary interventions, in a randomized order. For the normal lysine diet, participants will be asked to adhere to a specific diet for 1 week. Each study subject will receive 3 meals and 1-2 snacks per day during the study period.', 'interventionNames': ['Dietary Supplement: Controlled Diet']}, {'type': 'EXPERIMENTAL', 'label': 'High Lysine Diet', 'description': 'Participants will complete two one-week dietary interventions, in a randomized order. For the high lysine diet, participants will be asked to consume the same foods as in the normal lysine diet, but with the addition of lysine supplements (5g/day).', 'interventionNames': ['Dietary Supplement: Lysine', 'Dietary Supplement: Controlled Diet']}], 'interventions': [{'name': 'Lysine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lysine is an essential amino acid which is acquired from dietary sources.', 'armGroupLabels': ['High Lysine Diet']}, {'name': 'Controlled Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.', 'armGroupLabels': ['High Lysine Diet', 'Normal Lysine Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Cardiovascular Medicine Division', 'investigatorFullName': 'Jane Ferguson', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}