Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-01-22 @ 2:40 AM
Study NCT ID:
NCT03003793
Status:
COMPLETED
Last Update Posted:
2019-10-18
First Post:
2016-03-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Insulin Sensitivity in Patients With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lise.gether.01@regionh.dk', 'title': 'Lise Gether, MD', 'organization': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Healthy control subjects Hyperinsulinemic euglycemic clamp', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Atopic Dermatitis/Eczema Group', 'description': 'Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy control subjects Hyperinsulinemic euglycemic clamp'}, {'id': 'OG001', 'title': 'Atopic Dermatitis/Eczema Group', 'description': 'Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp', 'description': 'The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)', 'unitOfMeasure': 'mg glucose/kg body mass/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Healthy control subjects Hyperinsulinemic euglycemic clamp'}, {'id': 'FG001', 'title': 'Atopic Dermatitis/Eczema Group', 'description': 'Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Healthy control subjects Hyperinsulinemic euglycemic clamp'}, {'id': 'BG001', 'title': 'Atopic Dermatitis/Eczema Group', 'description': 'Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '3', 'groupId': 'BG000'}, {'value': '33', 'spread': '3', 'groupId': 'BG001'}, {'value': '33', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Atopic dermatitis duration', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No atopic dermaitits in this group', 'groupId': 'BG000'}, {'value': '28', 'spread': '3', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Only atopic dermaitits in one of the groups.', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body master index', 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '1', 'groupId': 'BG000'}, {'value': '24.5', 'spread': '1', 'groupId': 'BG001'}, {'value': '24.5', 'spread': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-25', 'studyFirstSubmitDate': '2016-03-01', 'resultsFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2016-12-27', 'lastUpdatePostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-25', 'studyFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls', 'timeFrame': 'Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp', 'description': 'The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis/Eczema', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': "The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many years. Novel research shows an association between the two conditions. While this relationship at least in theory can be explained by lifestyle factors, there is reason to believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that patients with atopic dermatitis are insulin resistant due to their chronic inflammatory state. Insulin resistance might play an unknown part in the increased frequency of type 2 diabetes among patients with atopic dermatitis. In the present project, the investigators aim to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control group (matched case-control study). The project is a close collaboration between The Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with atopic dermatitis are recruited from Department of Dermatology and Allergology at Gentofte Hospital.\n\nControl subjects are recruited from the Danish recruitment site "www.forsoegsperson.dk".', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe atopic dermatitis for at least 5 years\n* BMI \\< 30 kg/m2\n* HbA1c \\< 42 mmol/mol\n\nExclusion Criteria:\n\n* Diabetes\n* Prediabetes\n* First-degree relatives with diabetes\n* Chronic inflammatory diseases other than atopic dermatitis and asthma\n* Pregnancy\n* Breast-feeding\n* Daily intake of medications that are known to influence the glucose metabolism are not allowed one month before the study (e.g. asthma medicines and hormonal contraception).'}, 'identificationModule': {'nctId': 'NCT03003793', 'acronym': 'AD-IF', 'briefTitle': 'Insulin Sensitivity in Patients With Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Insulin Sensitivity in Patients With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'H-15010198'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Healthy control subjects', 'interventionNames': ['Diagnostic Test: Hyperinsulinemic euglycemic clamp']}, {'label': 'Atopic dermatitis/eczema group', 'description': 'Patients with atopic dermatitis', 'interventionNames': ['Diagnostic Test: Hyperinsulinemic euglycemic clamp']}], 'interventions': [{'name': 'Hyperinsulinemic euglycemic clamp', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hyperinsulinemic euglycemic clamp to detect insulin sensitivity', 'armGroupLabels': ['Atopic dermatitis/eczema group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Center for Diabetes Research, Gentofte Hospital, University of Copenhagen', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Filip K Knop, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Gentofte'}, {'name': 'Jacob P Thyssen, MD,PhD,DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Gentofte'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Filip Krag Knop', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}