Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-04-04 @ 11:39 AM
Study NCT ID:
NCT02673203
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2016-02-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], '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': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'renata.aguiar@yale.edu', 'phone': '(877) 925-3637', 'title': 'Renata Belfort De Aguiar, MD, PhD; Assistant Professor of Medicine (Endocrinology)', 'organization': 'Yale University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored for up to 7 days of wearing the CGM.', 'eventGroups': [{'id': 'EG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Changing Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.'}, {'id': 'OG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.57'}, {'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '0.38', 'upperLimit': '0.49'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3-5 days', 'description': 'The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the rate of changing glucose level (mg/dl/min).', 'unitOfMeasure': 'mg/dl/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Glucose Peak', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.'}, {'id': 'OG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.'}], 'classes': [{'categories': [{'measurements': [{'value': '119.5', 'groupId': 'OG000', 'lowerLimit': '111.5', 'upperLimit': '127.6'}, {'value': '121.5', 'groupId': 'OG001', 'lowerLimit': '113.1', 'upperLimit': '130.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3-5 days', 'description': 'The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl).', 'unitOfMeasure': 'mg/dl', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Glucose Nadir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.'}, {'id': 'OG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000', 'lowerLimit': '79.7', 'upperLimit': '90.4'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '81.4', 'upperLimit': '92.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3-5 days', 'description': 'The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl).', 'unitOfMeasure': 'mg/dl', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Glucose Peak and Nadir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.'}, {'id': 'OG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '38.8'}, {'value': '33.9', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '38.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3-5 days', 'description': 'The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the difference in glucose peak and nadir (mg/dl).', 'unitOfMeasure': 'mg/dl', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Daily Hunger Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.'}, {'id': 'OG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '6.5'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '6.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3-5 days', 'description': 'Average daily hunger was measured using a self-report scale. Hunger is measured on a scale from 1-10. 10 is the most hungry, 1 is the least hungry.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nutirion Intake: Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.'}, {'id': 'OG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2251.5', 'groupId': 'OG000', 'lowerLimit': '1841.1', 'upperLimit': '2661.8'}, {'value': '2167.8', 'groupId': 'OG001', 'lowerLimit': '1782.1', 'upperLimit': '2553.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3-5 days', 'description': 'Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily energy intake (kcal/day).', 'unitOfMeasure': 'kcal/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nutirion Intake: Carbohydrate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.'}, {'id': 'OG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.'}], 'classes': [{'categories': [{'measurements': [{'value': '261.1', 'groupId': 'OG000', 'lowerLimit': '212.2', 'upperLimit': '310.0'}, {'value': '251.8', 'groupId': 'OG001', 'lowerLimit': '204.5', 'upperLimit': '297.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3-5 days', 'description': 'Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily carbohydrate intake (g/day).', 'unitOfMeasure': 'g/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nutirion Intake: Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.'}, {'id': 'OG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000', 'lowerLimit': '68.3', 'upperLimit': '116.5'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '74.9', 'upperLimit': '120.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3-5 days', 'description': 'Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily fat intake (g/day).', 'unitOfMeasure': 'g/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nutirion Intake: Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.'}, {'id': 'OG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.9', 'groupId': 'OG000', 'lowerLimit': '81.2', 'upperLimit': '118.5'}, {'value': '80.9', 'groupId': 'OG001', 'lowerLimit': '61.9', 'upperLimit': '97.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3-5 days', 'description': 'Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily protein intake (g/day).', 'unitOfMeasure': 'g/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.'}, {'id': 'FG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Typical Weight Participants', 'description': 'Participants with a BMI \\<25 kg/m2.'}, {'id': 'BG001', 'title': 'Obese Non-diabetic Pariticpants', 'description': 'Non-diabetic participants with a BMI \\> 30 kg/m2.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '40.4', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '39', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '90.6', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '79.3', 'spread': '21.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'A1c (%)', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '33.4', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-24', 'size': 325166, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-13T09:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2016-02-01', 'resultsFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2016-02-02', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-21', 'studyFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Changing Glucose Level', 'timeFrame': '3-5 days', 'description': 'The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the rate of changing glucose level (mg/dl/min).'}, {'measure': 'Glucose Peak', 'timeFrame': '3-5 days', 'description': 'The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl).'}, {'measure': 'Glucose Nadir', 'timeFrame': '3-5 days', 'description': 'The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl).'}], 'secondaryOutcomes': [{'measure': 'Difference in Glucose Peak and Nadir', 'timeFrame': '3-5 days', 'description': 'The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the difference in glucose peak and nadir (mg/dl).'}, {'measure': 'Average Daily Hunger Rating', 'timeFrame': '3-5 days', 'description': 'Average daily hunger was measured using a self-report scale. Hunger is measured on a scale from 1-10. 10 is the most hungry, 1 is the least hungry.'}, {'measure': 'Nutirion Intake: Energy', 'timeFrame': '3-5 days', 'description': 'Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily energy intake (kcal/day).'}, {'measure': 'Nutirion Intake: Carbohydrate', 'timeFrame': '3-5 days', 'description': 'Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily carbohydrate intake (g/day).'}, {'measure': 'Nutirion Intake: Fat', 'timeFrame': '3-5 days', 'description': 'Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily fat intake (g/day).'}, {'measure': 'Nutirion Intake: Protein', 'timeFrame': '3-5 days', 'description': 'Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily protein intake (g/day).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glucose monitoring', 'hunger levels', 'food intake'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'To investigate whether the daily glucose profiles as assessed by continuous glucose monitoring for 1 week of normal weight and obese individuals relate to hunger levels and food intake.', 'detailedDescription': 'To evaluate the effect of blood glucose levels on eating behavior in a population of patients with diabetes in a free-living environment; the investigators plan to study lean healthy control subjects (BMI \\<25 kg/m2) and obese non-diabetic subjects (BMI \\> 30 kg/m2).\n\nThe participants who qualify will be invited to use the CGMS (DEXCOM G4 Platinum) for up to 7 days. On the visit for placement of the CGMS: 1) the participants will be explained by one of the study physicians how to use a glucometer (FreeStyle or Accu-Check), 2) they will have the CGMS inserted under the skin, and 3) they will be instructed how to fill up the food log (informational brochures are available at the end of the protocol. On the second visit (up to 7 days after the initial visit) the CGMS will be removed from the skin and the glucose meter and food log will be returned to the investigators.\n\nWhen this study was initially designed, it incorporated 2 additional arms in the study: T1DM and obese T2DM patients. These patients were never recruited for the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A1c \\< 10.5 %\n\nExclusion Criteria:\n\n* BMI \\<18 (no upper limit),\n* Creatinine \\> 1.5 mg/dL,\n* Hgb \\< 10 mg/dL,\n* ALT \\> 2.5 X ULN,\n* untreated thyroid disease,\n* uncontrolled hypertension,\n* known neurological disorders,\n* untreated psychiatric disorders,\n* use of antidepressants and psychiatric medications,\n* use of weight loss medications in the 6 months prior to the study,\n* malignancy,\n* smoking,\n* current or recent steroid use in last 3 months,\n* history of current illicit drug use;\n* for women: pregnancy, or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT02673203', 'briefTitle': 'Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects', 'orgStudyIdInfo': {'id': '1503015469'}, 'secondaryIdInfos': [{'id': '1K23DK098286-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23DK098286-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lean Healthy Control', 'description': '(BMI \\<25 kg/m2)', 'interventionNames': ['Device: Continuous Glucose Monitoring System (CGMS)', 'Behavioral: Food log']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Obese non-diabetic subject', 'description': 'BMI \\> 30 kg/m2', 'interventionNames': ['Device: Continuous Glucose Monitoring System (CGMS)', 'Behavioral: Food log']}], 'interventions': [{'name': 'Continuous Glucose Monitoring System (CGMS)', 'type': 'DEVICE', 'otherNames': ['DEXCOM G4 Platinum'], 'description': "The CGMS consists of 3 parts: sensor, transmitter and monitor. The small sensor measures the glucose levels from the interstitial tissue. The transmitter is attached on top of the sensor and connects wirelessly to the monitor. The sensor is sterile and comes in an unopened package. It has a plastic wire-like tip that is placed under the skin and continuously measures the glucose levels. One of the study physicians will insert the CGMS wire-like tip under the volunteer's skin with the use of the DEXCOM sensor insertion kit. The transmitter is snapped to the sensor pod and the sensor/transmitter unit will be attached to the skin with an adhesive patch. The monitor is the size of a small hand-held device with a digital screen that displays a graph showing the glucose levels from the previous 4-24 hours.", 'armGroupLabels': ['Lean Healthy Control', 'Obese non-diabetic subject']}, {'name': 'Food log', 'type': 'BEHAVIORAL', 'description': 'The Food Record will ask about amount and type of food consumed throughout the day. The participants will also register how hungry they are before the meal and how full they feel after they ate, and type and duration of physical activity', 'armGroupLabels': ['Lean Healthy Control', 'Obese non-diabetic subject']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519-1362', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Renata Belfort De Aguiar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}