Clinical trial NCT06976359: Association of C-reactive Protein-albumin-lymphocyte Index (CALLY) With All-cause Mortality in Diabetic Patients
Official title: The National Health and Nutrition Examination Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Diabetes
Lead sponsor: Kunming Children's Hospital
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 3988
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

(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.

Primary outcomes:
measure: mortality
timeFrame: 2025-5-8
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Kunming Children's Hospital
state: Yunnan
Study officials:
References: