Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-30 @ 11:59 PM
Study NCT ID:
NCT04317404
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2020-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Knee Steroid Injection and Blood Sugar Signatur
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], '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'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-17', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-19', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-injection glucose levels', 'timeFrame': '1 week', 'description': 'Blood glucose levels after injection of steroid to the knee'}], 'secondaryOutcomes': [{'measure': 'Post-injection adverse events', 'timeFrame': '1 week', 'description': 'Adverse events after injection of steroid to the knee'}, {'measure': 'KOOS Knee survey', 'timeFrame': '2 weeks', 'description': 'KOOS Knee survey administered before and after steroid injection to the knee'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'A prospective, observational study assessing the relationship between HbA1c level and the post-injection blood glucose signature. Participants will be non-diabetic, pre-diabetic, non-insulin dependent and insulin dependent type 2 diabetic patients who will be receiving a knee steroid injection. All of them will be consented a week prior to the injection, when the CGM sensor will be applied to the back of the upper arm. This will be removed a week after the injection. KOOS survey as well as VAS will be administered. Adverse events (e.g., change in medication or hospitalization) will be monitored throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Knee joint osteoarthritis requiring knee joint steroid injection', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at the Parkland Outpatient Clinic\n* Indication for unilateral knee joint steroid injection for the treatment of knee joint osteoarthritis\n\nExclusion Criteria:\n\n* Less than 18 years old\n* HbA1c \\> 12.0%\n* steroid exposure in the 3 months prior to Visit 1\n* 3 or more steroid injections in the preceding 12 months\n* known contraindication to steroid injection (adverse reaction or allergy, active infection, INR \\> 3.0)\n* lack of improvement with prior knee steroid injection\n* change in diabetic medication regimen in the last 1 month\n* significant change in diet within the last 1 month\n* current use of aspirin\n* allergy to adhesive\n* planned MRI, XR, or CT during the 2-week study period'}, 'identificationModule': {'nctId': 'NCT04317404', 'briefTitle': 'Knee Steroid Injection and Blood Sugar Signatur', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Identifying Variables Associated With Steroid-Induced Hyperglycemia Following Intra-articular Knee Injections Among Diabetic Patients', 'orgStudyIdInfo': {'id': 'STU 2019-1202'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic with Knee Osteoarthritis', 'description': 'HbA1c between 6.5% - 12.0% in the 3 months prior to Visit 1', 'interventionNames': ['Drug: 40 mg Triamcinolone acetonide']}, {'label': 'Pre-diabetic with Knee Osteoarthritis', 'description': 'HbA1c between 5.6% - 6.4% in the 3 months prior to Visit 1', 'interventionNames': ['Drug: 40 mg Triamcinolone acetonide']}, {'label': 'Non-diabetic with Knee Osteoarthritis', 'description': 'HbA1c \\< 5.6% in the 3 months prior to Visit 1', 'interventionNames': ['Drug: 40 mg Triamcinolone acetonide']}], 'interventions': [{'name': '40 mg Triamcinolone acetonide', 'type': 'DRUG', 'description': 'Unilateral knee steroid injection', 'armGroupLabels': ['Diabetic with Knee Osteoarthritis', 'Non-diabetic with Knee Osteoarthritis', 'Pre-diabetic with Knee Osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation for Physical Medicine and Rehabilitation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Reed Williams', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}