Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-26 @ 4:56 PM
Study NCT ID:
NCT04908904
Status:
COMPLETED
Last Update Posted:
2022-02-28
First Post:
2021-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Cafestol on Glucose Metabolism in Subjects With Type-2-diabetes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053400', 'term': 'cafestol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2021-05-27', 'studyFirstSubmitQcDate': '2021-05-27', 'lastUpdatePostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve for glucose', 'timeFrame': '-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution', 'description': 'Area under the curve for glucose during OGTT after ingestion of cafestol or placebo capsule'}], 'secondaryOutcomes': [{'measure': 'Area under the curve for insulin-response', 'timeFrame': '-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution', 'description': 'Area under the curve for insulin response during OGTT after ingestion of cafestol or placebo capsule'}, {'measure': 'Area under the curve for cafestol', 'timeFrame': '-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution', 'description': 'Area under the curve for cafestol during OGTT after ingestion of cafestol or placebo capsule'}, {'measure': 'Area under the curve for GLP-1', 'timeFrame': '-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution', 'description': 'Area under the curve for GLP-1 (glucagon-like peptide-1) during OGTT after ingestion of cafestol or placebo capsule'}, {'measure': 'Area under the curve for GIP', 'timeFrame': '-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution', 'description': 'Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide) during OGTT after ingestion of cafestol or placebo capsule'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 2'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Acute, double-blinded, randomized, cross-over cafestol intervention study with sixteen participants with T2D participating in two OGTTs.', 'detailedDescription': 'The study is an acute, double-blinded, randomized, cross-over intervention study with sixteen participants with T2D. Initially, a blood sample is obtained (t=-15 min) and at time point 0, the participants will ingest a tablet containing either 12 mg cafestol or placebo. Immediately hereafter an OGTT commences with ingestion of a 75 g glucose solution. In the following 3 hours blood samples are collected at time points 0, 15, 30, 60, 90, 120 and 180 min. The samples will be used for determination of plasma glucose, insulin and cafestol, as well as GLP-1 and GIP. After a one-week washout period, the subject will undergo the same set-up again, however now with the opposite intervention / placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes defined by standard Danish guidelines\n* HbA1c ≥48 mmol/mol unless successfully treated with antidiabetic drugs and/or diet/exercise intervention\n\nExclusion Criteria:\n\n* In treatment with insulin\n* Pregnancy\n* Planned pregnancy\n* Breastfeeding\n* Significant comorbidity expected to unable the subject from completing visits'}, 'identificationModule': {'nctId': 'NCT04908904', 'briefTitle': 'Acute Effects of Cafestol on Glucose Metabolism in Subjects With Type-2-diabetes.', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Acute Effects of Cafestol on Glucose Metabolism in Subjects With Type-2-diabetes.', 'orgStudyIdInfo': {'id': 'cafestol.acute.t2d'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cafestol', 'description': '12 mg cafestol', 'interventionNames': ['Dietary Supplement: Cafestol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Cafestol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Capsule with 12 mg cafestol', 'armGroupLabels': ['Cafestol']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo capsule without cafestol', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Aarhus N', 'country': 'Denmark', 'facility': 'Steno Diabetes Center Aarhus', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}