Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-31 @ 7:36 PM
Study NCT ID:
NCT06251895
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2024-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Systemic Immune-inflammation Index and Severity of Diabetic Ketoacidosis in Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016883', 'term': 'Diabetic Ketoacidosis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D007662', 'term': 'Ketosis'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SII', 'timeFrame': 'Day 1 (baseline)', 'description': 'SII = (neutrophil × platelet) / lymphocyte.'}], 'secondaryOutcomes': [{'measure': 'ICU admission', 'timeFrame': 'Hospital stay up to one week', 'description': 'need for ICU admission'}, {'measure': 'readmission', 'timeFrame': 'within 90 days', 'description': 'readmission because of DKA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complete blood count', 'diabetes mellitus', 'diabetic ketoacidosis', 'systemic immune inflammation index.'], 'conditions': ['Diabetic Ketoacidosis']}, 'referencesModule': {'references': [{'pmid': '35224769', 'type': 'BACKGROUND', 'citation': 'Dhatariya KK; Joint British Diabetes Societies for Inpatient Care. The management of diabetic ketoacidosis in adults-An updated guideline from the Joint British Diabetes Society for Inpatient Care. Diabet Med. 2022 Jun;39(6):e14788. doi: 10.1111/dme.14788. Epub 2022 Feb 27.'}, {'pmid': '36250645', 'type': 'BACKGROUND', 'citation': 'Glaser N, Fritsch M, Priyambada L, Rewers A, Cherubini V, Estrada S, Wolfsdorf JI, Codner E. ISPAD clinical practice consensus guidelines 2022: Diabetic ketoacidosis and hyperglycemic hyperosmolar state. Pediatr Diabetes. 2022 Nov;23(7):835-856. doi: 10.1111/pedi.13406. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Diabetic ketoacidosis (DKA) is the most serious metabolic complication of type 1 diabetes mellitus (T1DM). Insulin deficiency and inflammation play a role in the pathogenesis of DKA. The investigators aim to assess the systemic immune-inflammation index (SII) as a marker of severity among T1DM patients with DKA and without infection.', 'detailedDescription': 'Diabetic ketoacidosis (DKA) is one of the most severe acute metabolic complications of diabetes mellitus (DM). Therefore, DKA patients require prompt treatment and any delay in identifying severe DKA cases can lead to worse outcomes. DKA provokes a systemic inflammatory response through increased levels of various cytokines such as interleukin (IL)-8, IL-6, IL-10, tumor necrosis factor-alpha (TNF-α), and IL-1B. This will lead to cellular activation, cellular adhesion, increased oxidative stress, and endothelial damage, possibly contributing to complications. Consequently, surrogate markers of inflammation and immune status may help in the early identification of patients with severe DKA.\n\nThe systemic immune-inflammation index (SII) had a better prognostic value compared to NLR and PLR among cancer patients. Recently, studies have suggested a link between SII and increased risk of atherosclerotic cardiovascular disease (ASCVD), hepatic steatosis, and worse outcomes among hypertensive patients and patients with stroke.\n\nTherefore, the investigators aim to examine SII as a marker of severity in T1DM patients with DKA in an uninfected state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 DM hospitalized because of DKA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of T1DM\n* Hospitalization because of DKA\n* Age ≥ 12 years.\n\nExclusion Criteria:\n\n* Diagnosis of T2DM\n* Diagnosis of Infection\n* Renal impairment\n* Malignancy\n* ASCVD (atherosclerotic cardiovascular disease)\n* History of any medical condition or medications that can change CBC parameters or cause metabolic acidosis\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06251895', 'briefTitle': 'Association of Systemic Immune-inflammation Index and Severity of Diabetic Ketoacidosis in Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Jahra Hospital'}, 'officialTitle': 'Association of the Systemic Immune-inflammation Index (SII) and Severity of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Mellitus: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'J1 - 18072023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mild DKA', 'description': 'pH \\< 7.3 or serum bicarbonate \\<18 mmol/L', 'interventionNames': ['Other: DKA protocol']}, {'label': 'moderate DKA', 'description': 'pH \\< 7.2 or serum bicarbonate \\<10 mmol/L', 'interventionNames': ['Other: DKA protocol']}, {'label': 'severe DKA', 'description': 'pH \\< 7.1 or serum bicarbonate \\<5 mmol/L', 'interventionNames': ['Other: DKA protocol']}], 'interventions': [{'name': 'DKA protocol', 'type': 'OTHER', 'description': 'IV fluids and IV insulin as per guidelines. reference 1-2', 'armGroupLabels': ['mild DKA', 'moderate DKA', 'severe DKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2675', 'city': 'Kuwait', 'state': 'Al Jahra Governorate', 'country': 'Kuwait', 'facility': 'Jahra Hospital'}], 'overallOfficials': [{'name': 'MOHAMED AON, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Datasets analyzed during the current study will be available upon reasonable request from the corresponding author and after IRB approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jahra Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Aon', 'investigatorAffiliation': 'Jahra Hospital'}}}}