Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-27 @ 11:23 AM
Study NCT ID:
NCT05730634
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2023-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Statin Treatment on Arterial Wall Inflammation as Assessed With 68Ga-DOTATATE PET-CT
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': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DOTATATE coronary arteries', 'timeFrame': '3 months', 'description': 'Change in DOTATATE TBRmax coronary arteries after atorvastatin therapy'}], 'secondaryOutcomes': [{'measure': 'Change in splenic/bone marrow DOTATATE signal', 'timeFrame': '3 month', 'description': 'The secondary objective of this study is to assess the feasibility to measure splenic and bone-marrow inflammatory activity with 68Ga-Dotatate PET-CT in patients with diabetes mellitus, expressed as SUVmax'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['statin', 'dotatate', 'vascular inflammation', 'type 2 diabetes mellitus', 'pet/ct', 'positron emmission tomography'], 'conditions': ['Diabetes Mellitus, Type 2', 'Vascular Inflammation']}, 'referencesModule': {'references': [{'pmid': '37581619', 'type': 'DERIVED', 'citation': 'Oostveen RF, Kaiser Y, Stahle MR, Nurmohamed NS, Tzolos E, Dweck MR, Kroon J, Murphy AJ, Dey D, Slomka PJ, Verberne HJ, Stroes ESG, Hanssen NMJ. Atorvastatin lowers 68Ga-DOTATATE uptake in coronary arteries, bone marrow and spleen in individuals with type 2 diabetes. Diabetologia. 2023 Nov;66(11):2164-2169. doi: 10.1007/s00125-023-05990-9. Epub 2023 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'To study the effect of atorvastatin treatment on vascular uptake of 68Ga-DOTATATE in patients with Type 2 Diabetes.', 'detailedDescription': 'Well controlled patients with type 2 diabetes, who are statin naïve, will undergo atorvastatin treatment. Before and after treatment, patients will undergo a 68Ga-DOTATATE PET/CT, to evaluate the effect of treatment on vascular inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 50 years and older\n2. Diagnosed with diabetes mellitus type 2 and using oral glucose lowering therapy, insulin or combined glucose lowering therapy.\n3. Not on statin therapy or willing to stop with current statin therapy for 6 weeks prior to visit 2.\n4. HbA1c values below 65 mmol/L.\n5. Patients with "stable" diabetes mellitus, i.e. no changes in type of glucose lowering therapy and / or dosage of oral glucose lowering therapy in the past three months. No more than 20% change in dosage of insulin therapy (short and long acting) in the last three months.\n\nExclusion Criteria:\n\n1. History of cardiovascular disease (previous CV-event (MI / stroke) or known coronary artery disease (including acute coronary syndrome).\n2. History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of \\< 45 ml/min/1,73m2\n3. Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.\n4. Chronic or recent (\\< 1 month) infections and/or clinical signs of acute infection.\n5. History of auto-immune diseases.\n6. Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices.\n7. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.\n8. Planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons.\n9. Elevated liver enzymes (\\> 2 ULN of liver transaminases), acute liver failure or known liver disease.\n10. Prior medium to severe statin-related side effects or statin related hypersensitivity, i.e.\n\n (severe) muscle pains with and/or without myopathy .\n11. The concomitant use of statin contra-indicated drugs, including the use of CYP3A4 inhibitors (i.e. erytromycin, dilthiazem, amiodaron, verapamil, fluconazole, ciclosporin, stiripentol, itraconazol, ketoconazol, voriconazol, posaconazol, clarithromycin, ..), systemic use of fusidic acid and ciclosporin.\n12. Any contra-indications to the use of statins.'}, 'identificationModule': {'nctId': 'NCT05730634', 'acronym': 'CARAMEL', 'briefTitle': 'The Effect of Statin Treatment on Arterial Wall Inflammation as Assessed With 68Ga-DOTATATE PET-CT', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'The Effect of Statin Treatment on Arterial Wall Inflammation in Patients With Diabetes Mellitus as Assessed With 68Ga-DOTATATE PET-CT', 'orgStudyIdInfo': {'id': 'NL65001.018.18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Atorvastatin 40mg once daily.', 'interventionNames': ['Drug: Atorvastatin 40 Mg Oral Tablet']}], 'interventions': [{'name': 'Atorvastatin 40 Mg Oral Tablet', 'type': 'DRUG', 'description': 'Atorvastatin 40mg once daily for three months', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, location AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Nordin Hanssen', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}