Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-26 @ 9:30 AM
Study NCT ID:
NCT05298735
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatic Calcium Handling in Islet Beta Cells in Patients With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-25', 'studyFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pancreatic calcium-handling: Rate of change of pancreatic T1 values with manganese-enhanced magnetic resonance imaging', 'timeFrame': '30 minutes after contrast administration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Approximately 400,000 people are living with type 1 diabetes mellitus (T1DM) in the United Kingdom: one of the highest rates in the world. It is characterised by autoimmune loss of pancreatic beta cell mass leading to metabolic dysregulation, requiring lifelong insulin therapy. It is now recognised that there are micro-secretors of insulin and that preservation of insulin secretion in these cases is associated with decreased complications. Therefore, recent research has focussed on using immunomodulation to preserve pancreatic beta cell mass. Evaluation of novel therapies for T1DM requires reliable methods to measure beta-cell function, which is unattainable using traditional non-invasive imaging techniques. A new approach is manganese-enhanced magnetic resonance imaging (MEMRI). This proof-of-concept study was designed to investigate whether MEMRI can be used as a measure of beta-cell function in people with T1DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 1 diabetes mellitus (with or without detectable C-peptide levels)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* No regular medications\n* No known significant medical conditions\n\nExclusion Criteria:\n\n* Inability to consent\n* Renal failure (eGFR \\<30 mL/min/1.73 m2)\n* Standard MRI contraindications\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT05298735', 'acronym': 'Pancreas MEMRI', 'briefTitle': 'Pancreatic Calcium Handling in Islet Beta Cells in Patients With Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Pancreatic Calcium Handling in Islet Beta Cells in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'AC20142'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers', 'description': 'Healthy volunteers with no known significant medical conditions'}, {'label': 'Patients with type 1 diabetes', 'description': 'Patients with a diagnosis of type 1 diabetes (with or without detectable C-peptide)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'University of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}