Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-11 @ 10:17 PM
Study NCT ID:
NCT05597202
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2022-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2022-10-14', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in coronary 68Ga-Dotatate uptake after treatment.', 'timeFrame': '6 months', 'description': 'The within subject comparison of 68Ga-Dotatate uptake in the coronary arteries before and after semaglutide treatment, expressed as a difference in TBRmax.'}], 'secondaryOutcomes': [{'measure': 'Difference in bone marrow aspirates after treatment.', 'timeFrame': '6 months', 'description': 'The within subject comparison of bone marrow aspirates before and after semaglutide treatment, expressed as a difference in stem cell count.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'dotatate', 'bone marrow', 'semaglutide', 'vascular inflammation', 'glp1'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'To study the effect of type 2 diabetes (T2D) on vascular wall inflammation and hematopoietic stem cell composition in vivo, and whether these changes can be reversed with glucagon like peptide 1 receptor (GLP1R)-agonism.', 'detailedDescription': 'We will use 68Ga-Dotatate PET/CT scans, bone marrow aspirations and peripheral blood analyses to determine the effect of type 2 diabetes on vascular wall inflammation, and hematopoietic stem cell composition, and whether these changes can be reversed using high dose semaglutide treatment, up to 2.0mg subcutaneously per week, for a period of six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>50 years old\n* Diagnosed with type 2 diabetes\n* HbA1c \\>64mmol/mol\n\nExclusion Criteria:\n\n1. (History of) malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.\n2. Chronic or recent infections and/or clinical signs of infection and/or a plasma C-reactive protein above 10ng/ml\n3. Auto-immune diseases (including type 1 diabetes)\n4. Recent or chronic immunosuppressant or antibiotic usage\n5. Use of any GLP1R-agonist at baseline or prior intolerance to use of GLP1R-agonists.\n6. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.\n7. Uncontrolled hypertension (systolic blood pressure \\> 180mmHg, diastolic blood pressure \\> 100mmHg)\n8. Uncontrolled chronic inflammatory conditions, including gout.\n9. Women of childbearing age who are not using effective contraceptives.\n10. Heart failure New York Heart Association (NYHA) class IV at screening visit.\n11. Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) ≥ 2 times the upper limit of normal (ULN) at screening visit.\n12. Pancreatitis in medical history.'}, 'identificationModule': {'nctId': 'NCT05597202', 'acronym': 'DOTAFLAME', 'briefTitle': 'Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NL80519.018.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Will receive semaglutide treatment for 6 months, at the highest tolerable dose, up to a maximum of 2.0mg weekly.', 'interventionNames': ['Drug: Semaglutide, 2.0 mg/mL']}], 'interventions': [{'name': 'Semaglutide, 2.0 mg/mL', 'type': 'DRUG', 'description': 'Semaglutide 2.0 mg/mL, administered subcutaneously once per week for a period of 6 months.', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'R.F. Oostveen, MD', 'role': 'CONTACT', 'email': 'r.oostveen@amsterdamumc.nl', 'phone': '020 566 7050'}], 'facility': 'AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'R.F. Oostveen, MD', 'role': 'CONTACT', 'email': 'r.oostveen@amsterdamumc.nl', 'phone': '020 5667050'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nordin Hanssen', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}