Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00802204
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2008-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dopamine and Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D005951', 'term': 'Glucose Tolerance Test'}, {'id': 'D011788', 'term': 'Quality of Life'}, {'id': 'D031204', 'term': 'Caloric Restriction'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002149', 'term': 'Energy Intake'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'julia.dunn@va.gov', 'phone': '615-343-8389', 'title': 'Julia Dunn, MD', 'organization': 'Vanderbilt University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lean', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Obese', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Striatal DRD2 Receptor Binding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean Baseline'}, {'id': 'OG001', 'title': 'Obese Baseline'}, {'id': 'OG002', 'title': 'Obese Post-diet'}], 'classes': [{'title': 'caudate', 'categories': [{'measurements': [{'value': '28', 'spread': '3', 'groupId': 'OG000'}, {'value': '33', 'spread': '3', 'groupId': 'OG001'}, {'value': '32', 'spread': '3', 'groupId': 'OG002'}]}]}, {'title': 'putamen', 'categories': [{'measurements': [{'value': '33', 'spread': '3', 'groupId': 'OG000'}, {'value': '38', 'spread': '3', 'groupId': 'OG001'}, {'value': '36', 'spread': '4', 'groupId': 'OG002'}]}]}, {'title': 'ventral striatum', 'categories': [{'measurements': [{'value': '19', 'spread': '4', 'groupId': 'OG000'}, {'value': '22', 'spread': '3', 'groupId': 'OG001'}, {'value': '22', 'spread': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'describe.....'}, {'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Paired t-test to compare baseline and post-diet outcome measures', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after 8-10days VLCD', 'description': 'Region of interest compared to reference region to calculate binding potential', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD'}, {'type': 'PRIMARY', 'title': 'Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean Baseline'}, {'id': 'OG001', 'title': 'Obese Baseline'}, {'id': 'OG002', 'title': 'Obese Post-diet'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'spread': '2', 'groupId': 'OG000'}, {'value': '19', 'spread': '10', 'groupId': 'OG001'}, {'value': '11', 'spread': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post 8-10days after VLCD', 'description': 'microU/ml', 'unitOfMeasure': 'microU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean Baseline'}, {'id': 'OG001', 'title': 'Obese Baseline'}, {'id': 'OG002', 'title': 'Obese Post-diet'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'spread': '6', 'groupId': 'OG000'}, {'value': '87', 'spread': '9', 'groupId': 'OG001'}, {'value': '81', 'spread': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post 8-10days after VLCD', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Leptin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean Baseline'}, {'id': 'OG001', 'title': 'Obese Baseline'}, {'id': 'OG002', 'title': 'Obese Post-diet'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '5', 'groupId': 'OG000'}, {'value': '43', 'spread': '12', 'groupId': 'OG001'}, {'value': '34', 'spread': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post 8-10days after VLCD', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Acyl Ghrelin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean Baseline'}, {'id': 'OG001', 'title': 'Obese Baseline'}, {'id': 'OG002', 'title': 'Obese Post-diet'}], 'classes': [{'categories': [{'measurements': [{'value': '235', 'spread': '104', 'groupId': 'OG000'}, {'value': '78', 'spread': '55', 'groupId': 'OG001'}, {'value': '59', 'spread': '36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post 8-10days after VLCD', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Insulin Sensitivity From Oral Glucose Tolerance Test (OGTT_SI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean Baseline'}, {'id': 'OG001', 'title': 'Obese Baseline'}, {'id': 'OG002', 'title': 'Obese Post-diet'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'spread': '4', 'groupId': 'OG000'}, {'value': '4', 'spread': '3', 'groupId': 'OG001'}, {'value': '4', 'spread': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post 8-10days after VLCD', 'description': 'Insulin Sensitivity from Oral Glucose Tolerance Test was estimated using the minimal model method', 'unitOfMeasure': '10-4*min-1*microU-1*mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 lean enroll but only 8 complete. A ll lean complete study after baseline outcome measurements.\n\n19 obese enroll but only 18 complete baseline studies and of these 15 completed the VLCD'}, {'type': 'SECONDARY', 'title': 'Binge Eating Score Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lean'}, {'id': 'OG001', 'title': 'Obese'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'spread': '6', 'groupId': 'OG000'}, {'value': '12', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Increased scores indicate increased binge eating behaviors. Score 0-46', 'unitOfMeasure': 'score from questionnaire', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lean', 'description': 'BMI\\<\\~25kg/m2'}, {'id': 'FG001', 'title': 'Obese', 'description': 'BMI\\>/=30kg/m2'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '9 lean enroll but only 8 complete. The lean complete study after baseline outcome measurements.\n\n19 obese enroll but only 18 complete baseline outcome measurements and of these 15 completed the VLCD and post-outcome measurements'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lean'}, {'id': 'BG001', 'title': 'Obese'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '9', 'groupId': 'BG000'}, {'value': '39', 'spread': '8', 'groupId': 'BG001'}, {'value': '39', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American Participants', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian Participants', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '7', 'groupId': 'BG000'}, {'value': '104', 'spread': '17', 'groupId': 'BG001'}, {'value': '91', 'spread': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '2', 'groupId': 'BG000'}, {'value': '39', 'spread': '6', 'groupId': 'BG001'}, {'value': '33', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Beck Depression Inventory II(BDI-II)', 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '5', 'groupId': 'BG000'}, {'value': '7', 'spread': '6', 'groupId': 'BG001'}, {'value': '6', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '0-63 with higher scores indicating increased depressive symptoms. Scores above 20 indicate moderate depressive symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'OGTT_SI (Insulin Sensitivity from OGTT)', 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '3.98', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '6', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Insulin Sensitivity from Oral Glucose Tolerance Test was estimated using the oral minimal model method', 'unitOfMeasure': '(10-4min-1/µU*mL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin', 'classes': [{'categories': [{'measurements': [{'value': '6', 'spread': '2', 'groupId': 'BG000'}, {'value': '18', 'spread': '9', 'groupId': 'BG001'}, {'value': '14', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '(µU/ml)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glucose', 'classes': [{'categories': [{'measurements': [{'value': '82', 'spread': '6', 'groupId': 'BG000'}, {'value': '87', 'spread': '9', 'groupId': 'BG001'}, {'value': '86', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Leptin', 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '5', 'groupId': 'BG000'}, {'value': '43', 'spread': '12', 'groupId': 'BG001'}, {'value': '34', 'spread': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Acyl Ghrelin', 'classes': [{'categories': [{'measurements': [{'value': '235', 'spread': '104', 'groupId': 'BG000'}, {'value': '78', 'spread': '55', 'groupId': 'BG001'}, {'value': '132', 'spread': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Lean who are age and sex similar to obese will complete baseline outcome measurements only.\n\nObese will complete baseline outcome measurements then the VLCD intervention with post outcome measurements .'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2008-12-02', 'resultsFirstSubmitDate': '2016-07-14', 'studyFirstSubmitQcDate': '2008-12-03', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-29', 'studyFirstPostDateStruct': {'date': '2008-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Striatal DRD2 Receptor Binding', 'timeFrame': 'Baseline and after 8-10days VLCD', 'description': 'Region of interest compared to reference region to calculate binding potential'}, {'measure': 'Insulin', 'timeFrame': 'Baseline to post 8-10days after VLCD', 'description': 'microU/ml'}, {'measure': 'Glucose', 'timeFrame': 'Baseline to post 8-10days after VLCD'}, {'measure': 'Leptin', 'timeFrame': 'Baseline to post 8-10days after VLCD'}, {'measure': 'Acyl Ghrelin', 'timeFrame': 'Baseline to post 8-10days after VLCD'}, {'measure': 'Insulin Sensitivity From Oral Glucose Tolerance Test (OGTT_SI)', 'timeFrame': 'Baseline to post 8-10days after VLCD', 'description': 'Insulin Sensitivity from Oral Glucose Tolerance Test was estimated using the minimal model method'}], 'secondaryOutcomes': [{'measure': 'Binge Eating Score Questionnaire', 'timeFrame': 'Baseline', 'description': 'Increased scores indicate increased binge eating behaviors. Score 0-46'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Insulin Resistance', 'Neuroendocrine regulation', 'Eating behaviors', 'Dopamine signaling'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '30849082', 'type': 'DERIVED', 'citation': 'Dunn JP, Abumrad NN, Patterson BW, Kessler RM, Tamboli RA. Brief communication: beta-cell function influences dopamine receptor availability. PLoS One. 2019 Mar 8;14(3):e0212738. doi: 10.1371/journal.pone.0212738. eCollection 2019.'}, {'pmid': '28944597', 'type': 'DERIVED', 'citation': 'Dunn JP, Abumrad NN, Kessler RM, Patterson BW, Li R, Marks-Shulman P, Tamboli RA. Caloric Restriction-Induced Decreases in Dopamine Receptor Availability are Associated with Leptin Concentration. Obesity (Silver Spring). 2017 Nov;25(11):1910-1915. doi: 10.1002/oby.22023. Epub 2017 Sep 25.'}, {'pmid': '26599819', 'type': 'DERIVED', 'citation': 'Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.'}, {'pmid': '22432117', 'type': 'DERIVED', 'citation': 'Dunn JP, Kessler RM, Feurer ID, Volkow ND, Patterson BW, Ansari MS, Li R, Marks-Shulman P, Abumrad NN. Relationship of dopamine type 2 receptor binding potential with fasting neuroendocrine hormones and insulin sensitivity in human obesity. Diabetes Care. 2012 May;35(5):1105-11. doi: 10.2337/dc11-2250. Epub 2012 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'Obese individuals have fewer striatal dopamine type 2 receptors (DRD2) than normal weight individuals. Lower DRD2 levels are associated with addiction and a decreased sense of pleasure.Obesity is also associated with insulin resistance (poor insulin action).We propose that insulin resistance and low DRD2 are associated. Using PET imaging,we aim to determine DRD2 binding potential (BP) in the brain is associated with insulin resistance and neuroendocrine hormone levels. Obese participants will be compared to lean, gender and age similar participants. We also aim to determine the effect of caloric restriction on DRD2 BP in obese subjects', 'detailedDescription': 'In has been reported obese individuals have fewer striatal dopamine type 2 receptors (DRD2) compared to normal weight individuals congruent with diet induced obese rodent models and similar to models of addiction. Lower DRD2 levels are associated with addiction and a decreased sense of pleasure. Excessive weight gain also contributes to the onset of impaired insulin signaling (insulin resistance). In the brain insulin regulates monoamines and has trophic effects. We propose that the previous reports of low DRD2 in individuals with obesity will be associated with the degree of insulin resistance. Using PET imaging, we aim to determine DRD2 binding potential (BP) in the striatum and hypothesize these measurements will be associated with insulin resistance and potentially other neuroendocrine hormone levels. Obese participants will be compared to lean, sex and age similar participants. We also aim to determine the effect of caloric restriction on DRD2 BP in obese subjects. We hypothesize the caloric restriction will improve insulin resistance and that changes in DRD2 binding will be associated with changes in insulin signaling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-60 yrs\n* obese BMI \\> 30kg/m2 and Weight less than 350 lbs\n* lean control BMI 18-25kg/m2\n\nExclusion Criteria:\n\n* Structured exercise \\> equivalent to 30mins 5x week of walking times a week\n* History of Substance Abuse, including but exclusive to alcohol, cocaine, marijuana, heroin, nicotine\n* Current psychiatric disorder or significant h/o disorder\n* Use or any antidepressants or antipsychotics for last 3-6months or depot antipsychotics in the last 12 months\n* Any condition felt by PI or co-investigators to interfere with ability to complete the study\n* Inability to abstain from alcohol, physical exercise or \\> 1 cup of coffee or equivalent daily for 3 days prior to imaging studies\n* Significant co-morbidities including atherosclerotic disease, metabolic disease, liver or renal insufficiency or abnormality found on MRI\n* Any condition which would interfere with MRI or PET studies, e.g. claustrophobia, cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body which may interfere with MRI scanning\n* Subjects on medications determined by PI, ex. sibutramine, frequent benzodiazepines or related drugs, which could affect quality of study for last 3 months.'}, 'identificationModule': {'nctId': 'NCT00802204', 'briefTitle': 'Dopamine and Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Dopamine Receptor Availability and Insulin Resistance', 'orgStudyIdInfo': {'id': 'IRB#080861 and 061246'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lean controls', 'description': 'Lean complete baseline outcome measures only', 'interventionNames': ['Radiation: PET scan', 'Procedure: Oral glucose tolerance test', 'Procedure: MRI', 'Behavioral: Psychological scales to assess attitudes and behaviors related to eating and quality of life']}, {'type': 'EXPERIMENTAL', 'label': 'Obese', 'description': 'Obese completing baseline and post-VLCD outcome measures', 'interventionNames': ['Radiation: PET scan', 'Procedure: Oral glucose tolerance test', 'Procedure: MRI', 'Behavioral: Psychological scales to assess attitudes and behaviors related to eating and quality of life', 'Other: Caloric Restriction']}], 'interventions': [{'name': 'PET scan', 'type': 'RADIATION', 'description': 'Both lean and obese undergo a PET scan of the brain using the radioligand,fallypride \\[18F\\] at baseline. Obese subjects who complete caloric restriction will have repeat scan after diet.\n\nCompleted at baseline and post-VLCD', 'armGroupLabels': ['Lean controls', 'Obese']}, {'name': 'Oral glucose tolerance test', 'type': 'PROCEDURE', 'description': 'Subjects will be required to drink a glucose solution; blood samples will be taken over a 5-hour time period Completed at baseline by both lean and obese and in obese post-VLCD', 'armGroupLabels': ['Lean controls', 'Obese']}, {'name': 'MRI', 'type': 'PROCEDURE', 'description': 'An MRI of the brain and abdomen will be performed prior to PET scan One time at baseline in both lean and obese', 'armGroupLabels': ['Lean controls', 'Obese']}, {'name': 'Psychological scales to assess attitudes and behaviors related to eating and quality of life', 'type': 'BEHAVIORAL', 'description': 'A series of short psychological scales will be administered during the study. Completed at baseline', 'armGroupLabels': ['Lean controls', 'Obese']}, {'name': 'Caloric Restriction', 'type': 'OTHER', 'description': 'Obese participants only complete a short-term (\\~10days) very low calorie diet', 'armGroupLabels': ['Obese']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Julia P Dunn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Robert M Kessler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Julia P.Dunn,MD', 'investigatorAffiliation': 'Vanderbilt University'}}}}