Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 4:50 AM
Study NCT ID:
NCT06976359
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2025-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of C-reactive Protein-albumin-lymphocyte Index (CALLY) With All-cause Mortality in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'HDL, TC, BUN,SCR'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3988}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-08', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '2025-5-8', 'description': 'all-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'Based on retrospective cohort data from 3,988 diabetic patients in the NHANES database, this study is the first to show a significant negative correlation between the CALLY index and all-cause mortality in diabetic patients, with good predictive ability for their survival risk. Our findings can help clinicians better assess disease progression in diabetic patients and provide a reference for personalized, precision medicine.', 'detailedDescription': 'All analyses accounted for NHANES sample weights, clustering, and stratification. We used EmpowerStats (v4.1, www.empowerstats.com) and R software (v4.4.1, www.r-project.org). Continuous variables were expressed as weighted mean ± standard error (SE), and categorical variables as weighted percentages. Associations between the CALLY index and all-cause mortality were assessed using Cox proportional hazards models. Model 1 was the unadjusted crude model. Model 2 included adjustments for age, sex, race, BMI, PIR, education, smoking, and alcohol consumption. Model 3 was the fully adjusted model including additional covariates, HDL, TC, BUN, uric acid, SCR, physical activity, energy intake, hypertension, CVD. Kaplan-Meier survival curves were used to compare survival across CALLY quartiles; differences were assessed using log-rank tests. Nonlinear associations were examined with smoothed curve fitting. Subgroup analyses explored consistency across strata. ROC curves and AUC were used to compare the predictive performance of CALLY, SII, PLR, and NLR. P \\< 0.05 was considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study included 3,988 participants, with 1,821 deaths (weighted mortality rate: 41.7%) during a median follow-up of 131 months. Table 1 shows the baseline characteristics of participants, stratified by final mortality status. Compared to survivors, non-survivors were older (68.34 vs. 57.26 years), had a higher proportion of males (52.70% vs. 49.34%), lower educational attainment (38.15% vs. 24.50%), and higher rates of comorbid hypertension (69.44% vs. 60.50%) and cardiovascular disease (42.34% vs. 15.50%). Non-survivors also had a lower ln CALLY index (0.82 vs. 1.02, p = 0.0006). Other differences are shown in Table 1.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) self-reported doctor-diagnosed diabetes; (2) fasting blood glucose ≥ 7.0 mmol/L; (3) two-hour oral glucose tolerance test blood glucose ≥ 11.1 mmol/L; (4) glycated hemoglobin A1c (HbA1c) ≥ 6.5%; or (5) use of hypoglycemic medication.'}, 'identificationModule': {'nctId': 'NCT06976359', 'acronym': 'required', 'briefTitle': 'Association of C-reactive Protein-albumin-lymphocyte Index (CALLY) With All-cause Mortality in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': "Kunming Children's Hospital"}, 'officialTitle': 'The National Health and Nutrition Examination Survey', 'orgStudyIdInfo': {'id': '20250508CALLY'}, 'secondaryIdInfos': [{'id': 'The 14th Five-Year Plan Yunnan', 'type': 'OTHER', 'domain': "Kunming Children's Hospital"}]}, 'contactsLocationsModule': {'locations': [{'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': "Kunming Children's Hospital", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Kunming Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinician', 'investigatorFullName': 'Zhu Tian', 'investigatorAffiliation': "Kunming Children's Hospital"}}}}