Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2026-01-25 @ 8:52 AM
Study NCT ID:
NCT04089332
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2019-09-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Insulin Resistance in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005951', 'term': 'Glucose Tolerance Test'}, {'id': 'D062666', 'term': 'Vascular Access Devices'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.schrage@wisc.edu', 'phone': '608-262-7715', 'title': 'Dr. William Schrage', 'organization': 'University of Wisconsin - Madison'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study conduct was impacted by the COVID-19 pandemic. Safety issues with the target population during this time influenced whether participants completed any or all of the study visits.\n\nDue to the small sample size, the statistic tests are likely underpowered and should be interpreted with caution.'}}, 'adverseEventsModule': {'timeFrame': 'up to 1 year and 9 months (this was the longest any one participant was on study)', 'eventGroups': [{'id': 'EG000', 'title': 'Enrolled, Eligible', 'description': 'Single arm for eligible subjects\n\nOral Glucose Tolerance Test: Eligible subjects will undergo MRI scanning before and after oral glucose tolerance test.\n\n3 Tesla MRI: A 3 Tesla MRI will be used to assess brain structure, quantify cerebral blood flow and capture cerebral vessel structure at designated time points throughout the study visits.\n\nIntravenous Catheter: A blood sampling IV catheter will be used to draw blood samples at specific time points throughout each study visit to measure concentrations of glucose and insulin.\n\nCognitive Tests: A battery of cognitive tests will be completed by the subject.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 2, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Unrelated Broken Bone', 'notes': 'Subject dislocated left patella, not at study visit.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unrelated Hip Injury', 'notes': 'Subject reported sports-related hip injury approximately 1-month prior. Physician evaluated with no intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Linear Relationship Between HOMA-IR and Cognitive Function (R-squared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled, Eligible', 'description': 'Oral Glucose Tolerance Test (OGTT): Eligible subjects will undergo MRI scanning before and after oral glucose tolerance test.\n\n3 Tesla MRI: A 3 Tesla MRI will be used to assess brain structure, quantify cerebral blood flow and capture cerebral vessel structure at designated time points throughout the study visits.\n\nIntravenous Catheter: A blood sampling IV catheter will be used to draw blood samples at specific time points throughout each study visit to measure concentrations of glucose and insulin.\n\nCognitive Tests: A battery of cognitive tests will be completed by the subject.'}], 'classes': [{'title': 'WASI II (Verbal IQ) Measure of intellectual ability, sub-tests Vocabulary and Similarities', 'categories': [{'measurements': [{'value': '0.205', 'groupId': 'OG000'}]}]}, {'title': 'WASI II (Performance IQ) Measure of intellectual ability, sub-tests Block Design, Matrix Reasoning', 'categories': [{'measurements': [{'value': '0.299', 'groupId': 'OG000'}]}]}, {'title': 'NIH Toolbox (List Learning) A cognitive measure of working memory', 'categories': [{'measurements': [{'value': '0.738', 'groupId': 'OG000'}]}]}, {'title': 'NIH Toolbox (Oral Symbol Digit Test) A cognitive measure of processing speed (numbers/symbols)', 'categories': [{'measurements': [{'value': '0.0264', 'groupId': 'OG000'}]}]}, {'title': 'NIH Toolbox (Flanker Inhibitory Control and Attention) Executive function measure', 'categories': [{'measurements': [{'value': '0.186', 'groupId': 'OG000'}]}]}, {'title': 'NIH Toolbox (Pattern Comparison) A cognitive measure of processing speed (stimuli)', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'NIH Toolbox (Picture Sequence) A cognitive measure of episodic memory', 'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000'}]}]}, {'title': 'WRAML (Picture Memory) A general memory measure of picture recognition', 'categories': [{'measurements': [{'value': '0.0572', 'groupId': 'OG000'}]}]}, {'title': 'D-KEFS (Color Word Interference) A measure of cognitive flexibility through inhibition', 'categories': [{'measurements': [{'value': '0.000224', 'groupId': 'OG000'}]}]}, {'title': 'D-KEFS (Trail Making Test) A measure of mental flexibility (motor speed)', 'categories': [{'measurements': [{'value': '0.392', 'groupId': 'OG000'}]}]}, {'title': 'Peds QL (Child 8-12 / Teen 13-18) A measure of health-related quality of life (HRQOL) in children', 'categories': [{'measurements': [{'value': '0.481', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.162', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.4465', 'groupDescription': 'WASI II (Verbal IQ) vs HOMA-IR', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0.117'}, {'pValue': '0.082', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.6704', 'groupDescription': 'WASI II (Performance IQ) vs HOMA-IR', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0.221'}, {'pValue': '0.286', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.8486', 'groupDescription': 'NIH Toolbox (Flanker Inhibitory Control and Attention) vs HOMA-IR', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0.0503'}, {'pValue': '0.635', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.0266', 'groupDescription': 'NIH Toolbox (Pattern Comparison) vs HOMA-IR', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0'}, {'pValue': '0.061', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.1588', 'groupDescription': 'NIH Toolbox (Picture Sequence) vs HOMA-IR', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0.381'}, {'pValue': '0.479', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.099', 'groupDescription': 'WRAML (Picture Memory) vs. HOMA-IR', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0'}, {'pValue': '0.965', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0676', 'groupDescription': 'D-KEFS (Color-Word Interference) vs. HOMA-IR', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0'}, {'pValue': '0.039', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.0091', 'groupDescription': 'D-KEFS (Trail Making Test) vs. HOMA-IR', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0.324'}, {'pValue': '0.018', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4.2085', 'groupDescription': 'PedsQL (Child 8-12 / Teen 13-18) vs. HOMA-IR', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0.0423'}], 'paramType': 'NUMBER', 'timeFrame': 'data collected at baseline visit (HOMA-IR) and one other study visit (Cognitive Function Tests) (up to 4 hours total time of data collection over two visits - data collection not temporally dependent)', 'description': 'HOMA-IR was measured from each participant at baseline (up to 1 hour visit) and a battery of cognitive instruments (listed here) were measured at a different study visit (2-3 hours of time). A relationship between individual HOMA-IR and Cognitive Function was hypothesized and a measured via Linear Regression (R-squared).', 'unitOfMeasure': 'R-squared', 'reportingStatus': 'POSTED', 'populationDescription': 'This includes all the participants that completed the cognitive visit of the study. Because data collected in each visit was not dependent on other visits in a temporal manner, study visits occurred in any order.'}, {'type': 'PRIMARY', 'title': 'Change in Cerebral Blood Flow (CBF) as Determined by MRI (mL/100g/Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled, Eligible', 'description': 'Single arm for eligible subjects\n\nOral Glucose Tolerance Test: Eligible subjects will undergo MRI scanning before and after oral glucose tolerance test.\n\n3 Tesla MRI: A 3 Tesla MRI will be used to assess brain structure, quantify cerebral blood flow and capture cerebral vessel structure at designated time points throughout the study visits.\n\nIntravenous Catheter: A blood sampling IV catheter will be used to draw blood samples at specific time points throughout each study visit to measure concentrations of glucose and insulin.\n\nCognitive Tests: A battery of cognitive tests will be completed by the subject.'}], 'classes': [{'title': 'Perfusion of Gray Matter at Baseline', 'categories': [{'measurements': [{'value': '64.25666', 'spread': '11.24309', 'groupId': 'OG000'}]}]}, {'title': 'Perfusion of Gray Matter at Peak Insulin (Avg. 45 min)', 'categories': [{'measurements': [{'value': '66.96387836', 'spread': '13.93884706', 'groupId': 'OG000'}]}]}, {'title': 'Change in Perfusion of Gray Matter', 'categories': [{'measurements': [{'value': '2.707215114', 'spread': '5.642163965', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.558', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.1138', 'groupDescription': 'Change in Gray Matter Perfusion vs. HOMA-IR', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-square = 0'}, {'pValue': '0.057', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-5.8089', 'groupDescription': 'Baseline Gray Matter vs. HOMA-IR', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0.18'}], 'paramType': 'MEAN', 'timeFrame': '1 study visit, measured at baseline and peak insulin (45-60 minutes after baseline)', 'description': 'CBF will be measured via MRI before OGTT (baseline) and after OGTT at Peak insulin.', 'unitOfMeasure': 'mL/100g/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Linear Relationship Between Cerebral Blood Flow and Cognitive Function (R-squared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled, Eligible', 'description': 'Oral Glucose Tolerance Test: Eligible subjects will undergo MRI scanning before and after oral glucose tolerance test.\n\n3 Tesla MRI: A 3 Tesla MRI will be used to assess brain structure, quantify cerebral blood flow and capture cerebral vessel structure at designated time points throughout the study visits.\n\nIntravenous Catheter: A blood sampling IV catheter will be used to draw blood samples at specific time points throughout each study visit to measure concentrations of glucose and insulin.\n\nCognitive Tests: A battery of cognitive tests will be completed by the subject.'}], 'classes': [{'title': 'WASI II (Verbal IQ) Measure of intellectual ability, sub-tests Vocabulary and Similarities.', 'categories': [{'measurements': [{'value': '0.132', 'groupId': 'OG000'}]}]}, {'title': 'WASI II (Performance IQ) Measure of intellectual ability, sub-tests Block Design, Matrix Reasoning', 'categories': [{'measurements': [{'value': '0.119', 'groupId': 'OG000'}]}]}, {'title': 'NIH Toolbox (List Learning) A cognitive measure of working memory', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'NIH Toolbox (Oral Symbol Digit Test) A cognitive measure of processing speed (numbers/symbols)', 'categories': [{'measurements': [{'value': '0.0593', 'groupId': 'OG000'}]}]}, {'title': 'NIH Toolbox (Flanker Inhibitory Control and Attention) Executive function measure', 'categories': [{'measurements': [{'value': '0.366', 'groupId': 'OG000'}]}]}, {'title': 'NIH Toolbox (Pattern Comparison) A cognitive measure of processing speed (stimuli)', 'categories': [{'measurements': [{'value': '0.000497', 'groupId': 'OG000'}]}]}, {'title': 'NIH Toolbox (Picture Sequence) A cognitive measure of episodic memory', 'categories': [{'measurements': [{'value': '0.0688', 'groupId': 'OG000'}]}]}, {'title': 'WRAML (Picture Memory) A general memory measure of picture recognition', 'categories': [{'measurements': [{'value': '0.185', 'groupId': 'OG000'}]}]}, {'title': 'D-KEFS (Color-Word Interference) A measure of cognitive flexibility through inhibition', 'categories': [{'measurements': [{'value': '0.234', 'groupId': 'OG000'}]}]}, {'title': 'D-KEFS (Trail Making Test) A measure of mental flexibility (motor speed)', 'categories': [{'measurements': [{'value': '0.00466', 'groupId': 'OG000'}]}]}, {'title': 'PedsQL (Child 8-12 / Teen 13-18) A measure of health-related quality of life (HRQOL) in children', 'categories': [{'measurements': [{'value': '0.0344', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.377', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.4465', 'groupDescription': 'WASI II (Verbal IQ) vs. Cerebral Blood Flow', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0'}, {'pValue': '0.402', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.6704', 'groupDescription': 'WASI II (Performance IQ) vs. Cerebral Blood Flow', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0'}, {'pValue': '0.203', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.8486', 'groupDescription': 'NIH Toolbox (Flanker Inhibitory Control and Attention) vs. Cerebral Blood Flow', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0.207'}, {'pValue': '0.967', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.0266', 'groupDescription': 'NIH Toolbox (Pattern Comparison) vs. Cerebral Blood Flow', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0'}, {'pValue': '0.616', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.1588', 'groupDescription': 'NIH Toolbox (Picture Sequence) vs. Cerebral Blood Flow', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0'}, {'pValue': '0.287', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.099', 'groupDescription': 'WRAML (Picture Memory) vs. Cerebral Blood Flow', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0.0497'}, {'pValue': '0.225', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0676', 'groupDescription': 'D-KEFS (Color-Word Interference) vs. Cerebral Blood Flow', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0.106'}, {'pValue': '0.872', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.0091', 'groupDescription': 'D-KEFS (Trail Making Test) vs. Cerebral Blood Flow', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0'}, {'pValue': '0.66', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4.2085', 'groupDescription': 'PedsQL (Child 8-12 / Teen 13-18) vs. Cerebral Blood Flow', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Adjusted R-squared = 0'}], 'paramType': 'NUMBER', 'timeFrame': 'data collected at baseline (CBF - up to 1 hour) and Cognitive Function data collected at another study visit (up to 3 hours), data collection over 2 study visits up to 4 hours total, data collection not temporally dependent', 'description': 'Cerebral Blood Flow was measured from each participant at baseline (without OGTT MRI Visit) and a battery of cognitive instruments (those listed below) were measured at a different study visit. A relationship between individual Cerebral Blood Flow and Cognitive Function was hypothesized and a measured via Linear Regression (R-squared).', 'unitOfMeasure': 'R-squared', 'reportingStatus': 'POSTED', 'populationDescription': 'This includes all the participants that completed the cognitive visit of the study. Because data collected in each visit was not dependent on other visits in a temporal manner, study visits occurred in any order.'}, {'type': 'PRIMARY', 'title': 'Mediation Analysis of the Indirect Effect of Cerebral Blood Flow on Insulin Resistance and Cognitive Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled, Eligible', 'description': 'Single arm for eligible subjects\n\nOral Glucose Tolerance Test: Eligible subjects will undergo MRI scanning before and after oral glucose tolerance test.\n\n3 Tesla MRI: A 3 Tesla MRI will be used to assess brain structure, quantify cerebral blood flow and capture cerebral vessel structure at designated time points throughout the study visits.\n\nIntravenous Catheter: A blood sampling IV catheter will be used to draw blood samples at specific time points throughout each study visit to measure concentrations of glucose and insulin.\n\nCognitive Tests: A battery of cognitive tests will be completed by the subject.'}], 'classes': [{'title': 'HOMA-IR vs WASii- Verbal (Grey Matter Baseline)', 'categories': [{'measurements': [{'value': '1.6787', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs WASii-Performance (grey Matter Baseline)', 'categories': [{'measurements': [{'value': '-3.3431', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs WRAML (Grey Matter Baseline)', 'categories': [{'measurements': [{'value': '-0.8194', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs DKEFS Trail Making (Grey Matter Baseline)', 'categories': [{'measurements': [{'value': '-0.1702', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs DKEFS Inhibition Stroop (Grey Matter Baseline)', 'categories': [{'measurements': [{'value': '-0.2095', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs PEDS QL Child Report (Grey Matter Baseline)', 'categories': [{'measurements': [{'value': '30.7925', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs NIH Toolbox Verbal List Learning (Grey Matter Baseline)', 'categories': [{'measurements': [{'value': '0.5834', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs NIH Toolbox Oral Digit Symbol (Grey Matter Baseline)', 'categories': [{'measurements': [{'value': '6.98', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs NIH Toolbox Flanker (Grey Matter Baseline)', 'categories': [{'measurements': [{'value': '1.0747', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs NIH Toolbox Pattern Comparison (Grey Matter Baseline)', 'categories': [{'measurements': [{'value': '2.3718', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs NIH Toolbox Picture Memory (Grey Matter Baseline)', 'categories': [{'measurements': [{'value': '-0.9954', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs WASii- Verbal (Grey Matter Change with OGTT)', 'categories': [{'measurements': [{'value': '-0.9125', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs WASii-Performance (grey Matter Change with OGTT)', 'categories': [{'measurements': [{'value': '-2.8222', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs WRAML (Grey Matter Change with OGTT)', 'categories': [{'measurements': [{'value': '-0.0008', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs DKEFS Trail Making (Grey Matter Change with OGTT)', 'categories': [{'measurements': [{'value': '0.1719', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs DKEFS Inhibition Stroop (Grey Matter Change with OGTT)', 'categories': [{'measurements': [{'value': '-0.3754', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs PEDS QL Child Report (Grey Matter Change with OGTT)', 'categories': [{'measurements': [{'value': '-7.4081', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs NIH Toolbox Verbal List Learning (Grey Matter Change with OGTT)', 'categories': [{'measurements': [{'value': '0.2067', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs NIH Toolbox Oral Digit Symbol (Grey Matter Change with OGTT)', 'categories': [{'measurements': [{'value': '-2.1898', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs NIH Toolbox Flanker (Grey Matter Change with OGTT)', 'categories': [{'measurements': [{'value': '-2.8883', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs NIH Toolbox Pattern Comparison (Grey Matter Change with OGTT)', 'categories': [{'measurements': [{'value': '0.5842', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR vs NIH Toolbox Picture Memory (Grey Matter Change with OGTT)', 'categories': [{'measurements': [{'value': '-1.5724', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion (up to 2 years)', 'description': 'Mediation analysis is a statistical method used to explain the influence of an outside variable (mediator) that may modify the direct relationship between the Independent (X) and Dependent variable (Y).\n\n(X - Mediator - Y)\n\nMediation analysis was used to explore the impact of cerebral blood flow on the relationship between HOMA-IR and cognitive function. This analysis was conducted on 11 separate cognitive function tests, looking at verbal skills, memory, executive function, and self-reported quality of life rating. In the first set of analyses, the mediator was "grey matter baseline", which is the cerebral blood flow in the resting state. The second set of analyses, the mediator was "grey matter change with OGTT", which is the cerebral blood flow changing from rest to response from Oral Glucose Tolerance Test (OGTT).\n\nPositive/negative effect numbers indicated that the total effect of the relationship was positive/negative.', 'unitOfMeasure': 'beta value', 'reportingStatus': 'POSTED', 'populationDescription': 'Mediation analysis was conducted on a limited data set due to the low number of participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrolled, Eligible', 'description': 'Oral Glucose Tolerance Test: Eligible subjects will undergo MRI scanning before and after oral glucose tolerance test.\n\n3 Tesla MRI: A 3 Tesla MRI will be used to assess brain structure, quantify cerebral blood flow and capture cerebral vessel structure at designated time points throughout the study visits.\n\nIntravenous Catheter: A blood sampling IV catheter will be used to draw blood samples at specific time points throughout each study visit to measure concentrations of glucose and insulin.\n\nCognitive Tests: A battery of cognitive tests will be completed by the subject.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Completed Cognitive Tests', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Completed OGTT', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Completed MRI Structural Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Completed With Data to Analyze', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Participants With Data for Change in CBF', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'COVID-19 Pandemic safety issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Moved in the MRI, no analysis possible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Completed only OGTT, no analysis possible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled from October 2019 to April 2022. Participants were 12-18 years old during Covid-19 pandemic, and thus had very delayed access to vaccines, limiting enrollment. Pandemic related safety issues effected study conduct. Not all enrolled participants completed all (up to 5, 3 for the primary aims) study visits as a result. Because the data collected in each visit was not dependent on the other visit in a temporal manner, the study visits could occur in any order.', 'preAssignmentDetails': '34 participants were consented, but due to the Covid-19 pandemic, only 23 participants started the study (completed at least 1 study visit).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled, Eligible', 'description': 'Oral Glucose Tolerance Test: Eligible subjects will undergo MRI scanning before and after oral glucose tolerance test.\n\n3 Tesla MRI: A 3 Tesla MRI will be used to assess brain structure, quantify cerebral blood flow and capture cerebral vessel structure at designated time points throughout the study visits.\n\nIntravenous Catheter: A blood sampling IV catheter will be used to draw blood samples at specific time points throughout each study visit to measure concentrations of glucose and insulin.\n\nCognitive Tests: A battery of cognitive tests will be completed by the subject.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.53', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '18'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', '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': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Demographics provided for the 15 participants for whom enough data was collected to analyze the relationship between HOMA-IR, Cognitive Abilities, and Cerebral Blood Flow.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-24', 'size': 1241409, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-01T16:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2019-09-03', 'resultsFirstSubmitDate': '2023-08-01', 'studyFirstSubmitQcDate': '2019-09-12', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-28', 'studyFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Linear Relationship Between HOMA-IR and Cognitive Function (R-squared)', 'timeFrame': 'data collected at baseline visit (HOMA-IR) and one other study visit (Cognitive Function Tests) (up to 4 hours total time of data collection over two visits - data collection not temporally dependent)', 'description': 'HOMA-IR was measured from each participant at baseline (up to 1 hour visit) and a battery of cognitive instruments (listed here) were measured at a different study visit (2-3 hours of time). A relationship between individual HOMA-IR and Cognitive Function was hypothesized and a measured via Linear Regression (R-squared).'}, {'measure': 'Change in Cerebral Blood Flow (CBF) as Determined by MRI (mL/100g/Min)', 'timeFrame': '1 study visit, measured at baseline and peak insulin (45-60 minutes after baseline)', 'description': 'CBF will be measured via MRI before OGTT (baseline) and after OGTT at Peak insulin.'}, {'measure': 'Linear Relationship Between Cerebral Blood Flow and Cognitive Function (R-squared)', 'timeFrame': 'data collected at baseline (CBF - up to 1 hour) and Cognitive Function data collected at another study visit (up to 3 hours), data collection over 2 study visits up to 4 hours total, data collection not temporally dependent', 'description': 'Cerebral Blood Flow was measured from each participant at baseline (without OGTT MRI Visit) and a battery of cognitive instruments (those listed below) were measured at a different study visit. A relationship between individual Cerebral Blood Flow and Cognitive Function was hypothesized and a measured via Linear Regression (R-squared).'}, {'measure': 'Mediation Analysis of the Indirect Effect of Cerebral Blood Flow on Insulin Resistance and Cognitive Function', 'timeFrame': 'through study completion (up to 2 years)', 'description': 'Mediation analysis is a statistical method used to explain the influence of an outside variable (mediator) that may modify the direct relationship between the Independent (X) and Dependent variable (Y).\n\n(X - Mediator - Y)\n\nMediation analysis was used to explore the impact of cerebral blood flow on the relationship between HOMA-IR and cognitive function. This analysis was conducted on 11 separate cognitive function tests, looking at verbal skills, memory, executive function, and self-reported quality of life rating. In the first set of analyses, the mediator was "grey matter baseline", which is the cerebral blood flow in the resting state. The second set of analyses, the mediator was "grey matter change with OGTT", which is the cerebral blood flow changing from rest to response from Oral Glucose Tolerance Test (OGTT).\n\nPositive/negative effect numbers indicated that the total effect of the relationship was positive/negative.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'The growing population of adolescents with insulin resistance (IR) is predicted to create a large public health burden in the next few decades. This study examines the function of brain blood vessels and cognitive function, to test if increasing severity of IR in adolescents is related to reduced cognitive function and reduced brain blood vessel function. Findings from this study may help create treatments to delay or prevent some of the negative effects of IR on cognitive and vascular health.', 'detailedDescription': 'One in five American adolescents is obese. Up to half of those are already exhibiting insulin resistance (IR), a hallmark of metabolic syndrome and diabetes linked to serious life-altering health disorders, including cardiovascular and cerebrovascular disease. In adults, IR negatively affects brain structure and function and is reflected in lower regional brain volumes, perfusion, increased white matter hyperintensities and abnormal neuropsychological status, especially affecting memory and attention-all changes associated with accelerated cognitive and brain aging and increased risk of dementia. In an analogous fashion, a limited set of literature suggests adolescents with IR exhibit similar brain changes during maturation. The investigators hypothesize that the brains of obese adolescents are more susceptible to insults of IR during rapid brain development, positioning them on an abnormal cognitive trajectory, and predisposing them to issues related to learning, behavioral stress responses, and depression.\n\nWhile the metabolic consequences of IR are well described in adolescence, the impact of IR on their neurocognitive status (intelligence, memory, attention, executive function, processing speed) and cerebrovascular function and their interactions remains largely unexplored. This is important since in addition to its classic role as a metabolic hormone, insulin acts as a vasodilator and supports neurotrophic signaling in healthy humans. Therefore, dysfunctional insulin signaling may hold tremendous influence over brain health in adolescents during this vital period of brain development. New insight is required to understand where, when, and how IR negatively transforms brain health, including whether a dose-response exists between IR severity and anomalies in brain and cognition.\n\nThe long-term goal of this research program is to determine the influence of IR on brain development in adolescents through the relationships between neurocognition and cerebral blood supply. The primary goal of the current project is to quantify fundamental neurocognitive and cerebrovascular function in relation to the severity of IR. The central hypothesis is that as IR worsens: a) subtle but meaningful neurocognitive declines emerge; b) regional brain perfusion is reduced primarily in areas linked to learning and memory despite preserved resting global cerebral blood flow (CBF); c) acute insulin surges exacerbate regional hypoperfusion, and d) cognitive scores will be lower, mediated in part by insulin-stimulated hypoperfusion.\n\nParticipants will be recruited primarily from pediatric and pediatric endocrinology clinics via our collaborator, Dr. Aaron Carrel, and his staff in UWHC Pediatric Endocrinology. Additionally, participants will be recruited from the greater Madison, WI community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 12-18 years inclusive\n* Typically developing and cognitively intact\n\nExclusion Criteria:\n\n* Diabetes (≥126 mg dL-1 fasting glucose)\n* Insulin treatment or sensitizing drugs\n* Diagnosis of kidney, pulmonary, or heart disease\n* Current smoking (defined as use of nicotine \\>5 times in the past month)\n* Pregnancy\n* Neurological or developmental disorders (e.g., intellectual disability, autism)\n* Significant head injury or medical conditions (e.g., concussion, encephalopathy, seizure disorder)\n* Inability to undergo the MRI procedure\n* Weight less than 94.5 lbs (42.9 kg) to adhere to safety guidelines regarding blood sampling and OGTT administration\n* Tanner Stage \\<3\n* Any other circumstance deemed by the PI not addressed above'}, 'identificationModule': {'nctId': 'NCT04089332', 'briefTitle': 'Insulin Resistance in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Insulin Resistance, Cognitive Health, and Perfusion of the Adolescent Brain', 'orgStudyIdInfo': {'id': '2019-0361'}, 'secondaryIdInfos': [{'id': '1R21HD097510-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21HD097510-01A1', 'type': 'NIH'}, {'id': 'A176000', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'EDUC/KINESIOLOGY/KINESIOLOG', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '19PRE34450141', 'type': 'OTHER_GRANT', 'domain': 'American Heart Association'}, {'id': 'Protocol Version 9/24/2021', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enrolled, eligible', 'description': 'Single arm for eligible subjects', 'interventionNames': ['Other: Oral Glucose Tolerance Test (OGTT)', 'Device: 3 Tesla MRI', 'Device: Intravenous Catheter', 'Other: Cognitive Tests']}], 'interventions': [{'name': 'Oral Glucose Tolerance Test (OGTT)', 'type': 'OTHER', 'otherNames': ['OGTT'], 'description': 'Eligible subjects will undergo MRI scanning before and after oral glucose tolerance test.', 'armGroupLabels': ['Enrolled, eligible']}, {'name': '3 Tesla MRI', 'type': 'DEVICE', 'otherNames': ['MRI'], 'description': 'A 3 Tesla MRI will be used to assess brain structure, quantify cerebral blood flow and capture cerebral vessel structure at designated time points throughout the study visits.', 'armGroupLabels': ['Enrolled, eligible']}, {'name': 'Intravenous Catheter', 'type': 'DEVICE', 'otherNames': ['Cath'], 'description': 'A blood sampling IV catheter will be used to draw blood samples at specific time points throughout each study visit to measure concentrations of glucose and insulin.', 'armGroupLabels': ['Enrolled, eligible']}, {'name': 'Cognitive Tests', 'type': 'OTHER', 'description': 'A battery of cognitive tests will be completed by the subject.', 'armGroupLabels': ['Enrolled, eligible']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'William Schrage, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}