NCT06913153

Brief Summary

The goal of this observational study is to reveal the natural history of diabetes and the occurrence and development patterns of its complications, to evaluate the effectiveness of diabetes interventions, and to assess the health and medical burdens caused by diabetes in Tianjin, based on the medical records and health big data in Tianjin and correspondingly constructed diabetes-specific cohort.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396,983

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
2 months until next milestone

Results Posted

Study results publicly available

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

16 years

First QC Date

March 29, 2025

Results QC Date

April 10, 2025

Last Update Submit

May 7, 2025

Conditions

Keywords

cohort studydiabets complicationetiologyclinical epidemiologyhealth economic evaluation

Outcome Measures

Primary Outcomes (1)

  • Diabetes Complications

    Diabetic Complications: diabetic retinopathy,diabetic nephropathy,cerebral infarction,coronary artery disease The diagnosis of coronary artery disease is based on a comprehensive assessment of the degree of coronary artery stenosis and evidence of myocardial ischemia, taking into account risk factors and clinical symptoms, and exclusion of other similar diseases. The diagnostic criteria for diabetic nephropathy are history of diabetes: clear and long history of diabetes, Urine protein test:Urinary microalbumin excretion rate (UACR) is a key indicator for early diagnosis, with a normal value of less than 30mg/g, 30-300m Diagnosis of diabetic retinopathy by fundus examination. Diagnostic criteria for cerebral infarction are ICD codes or the doctor's diagnosis. Data collection through chart review, patient self-reporting, imaging

    Baseline and week 520

Secondary Outcomes (2)

  • Glycemic Control

    baseline and week 520

  • Death

    baseline and week 520

Interventions

DietBEHAVIORAL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study was conducted through the University-Enterprise Joint Laboratory for Diabetes Epidemiology Research at Tianjin Medical University, China. Longitudinal multi-source health big data from 2009 to 2024 (encompassing 396,983 individuals with diabetes treated in secondary and tertiary healthcare facilities in Tianjin) were integrated to establish a representative diabetes population cohort.

You may qualify if:

  • Patients diagnosed with diabetes
  • Patients with three or more recorded visits
  • The following information was complete at the first visit: age, sex, Blood Glucoseor ,glycated hemoglobin(HbA1c)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Diet

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Results Point of Contact

Title
Zhenqiang Song, M.S., Associate Professor and Master's Supervisor
Organization
Tianjin Medical University

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher,Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

January 1, 2009

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 25, 2025

Results First Posted

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Access to raw datasets is restricted under legally binding agreements with the collaborating institutions, as these prohibit data sharing with third parties. However, de-identified aggregate findings, statistical summaries, or the study protocol can be made available upon reasonable request to the Principal Investigator (PI).