DiabetesrequiredNCT06976359
Association of C-reactive Protein-albumin-lymphocyte Index (CALLY) With All-cause Mortality in Diabetic Patients
An observational study of Diabetes, run by Kunming Children's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 3,988 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2025to 8 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The National Health and Nutrition Examination Survey
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.
Read the 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.
- Conditions
- Diabetes
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
all-cause mortality
Measured: 2025-5-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start8 Apr 2025
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,988 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kunming Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Tian, Kunming Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976359
- Sponsor's protocol ID
- 20250508CALLY
- Other IDs
- The 14th Five-Year Plan Yunnan
- Acronym
- required
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Health and Nutrition Examination Survey
- ClinicalTrials.gov ID
- NCT06976359
- Acronym / sponsor ID
- required / 20250508CALLY
- Conditions
- Diabetes
- Keywords
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,988 participants (actual)
- Lead sponsor
- Kunming Children's HospitalUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: 2025-5-8
all-cause mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Kunming Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 2025-5-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.