Tianjin Diabetes and Health Cohort Study

An observational study of Diabetes Mellitus, run by Tianjin Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Diabetes Mellitus
What is being tested?: Diet
Type of treatment: Lifestyle or therapy programme
How many people: 396,983 participants
Where: No sites listed yet
Study dates: 1 Jan 2009to 31 Dec 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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)

Who cannot join

none

About this study

Read the detailed description

This study was conducted through the University-Enterprise Joint Laboratory for Diabetes Epidemiology Research at Tianjin Medical University. Retrospective and ongoing medical records and health big data from 396983 diabetes patients treated in secondary and tertiary hospitals in Tianjin between 2009 and 2024 were collected to establish a diabetes population cohort. Using advanced data mining techniques, multi-dimensional data including electronic health records (EHRs), medical imaging data, and wearable device metrics were analyzed.

Conditions: Diabetes Mellitus
Being tested: Diet
Keywords: cohort study, diabets complication, etiology, clinical epidemiology, health economic evaluation
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DietBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline and week 520

Secondary outcomes (2)

Glycemic Control
Average level of glucose: including Glycated Hemoglobin (HbA1c), the mean of fasting glucose(FG) Glucose Variability: including standard deviation, coefficient of variation of HbA1c and FG.
Measured: baseline and week 520
Death
death from all cause, diabetes complications, and cancer.
Measured: baseline and week 520

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 200931 Dec 2024

First posted6 Apr 2025
Study start1 Jan 2009
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies 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: 396,983 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06913153
Sponsor's protocol ID: TMUhMEC20250002
Status last verified: May 2025
First submitted: 29 Mar 2025
Last updated: 25 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tianjin Diabetes and Health Cohort Study
ClinicalTrials.gov ID: NCT06913153
Acronym / sponsor ID: TMUhMEC20250002
Conditions: Diabetes Mellitus
Keywords: cohort study, diabets complication, etiology, clinical epidemiology, health economic evaluation
Study type: Observational
Recruitment status: Completed
Enrolment: 396,983 participants (actual)
Lead sponsor: Tianjin Medical UniversityUniversity, hospital or other
Study start: 1 Jan 2009 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 6 Apr 2025 (actual)
Results: Posted 25 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (1 listed)

none

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diet	Behavioural	–

Primary outcome

Diabetes Complications
Time frame: Baseline and week 520
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

2 secondary outcomes

Glycemic Control
Time frame: baseline and week 520
Death
Time frame: baseline and week 520

Results and safety

Results posted to the registry on 25 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort Comparising Patients With Diabetes	396,983	396,983

Primary outcome: Diabetes Complications

Time frame: Baseline and week 520. Count of participants. Unit: Participants

Measure	Coronary Artery Disease n = 396983	Cerebral Infarction n = 396983	Diabetic Retinopathy n = 396983	Diabetic Nephropathy n = 396983
Patients presenting with any of the aforementioned clinical outcomes	10263	97864	59029	69822
Patients presenting without any of the aforementioned clinical outcomes	386720	299119	337954	327161

Population analysed: All the participants in the cohort are included in the analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: This study is a real-world observational study and information on adverse events are not available .. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort Comparising Patients With Diabetes	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. 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).

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by Tianjin Medical University.

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 3 inclusion and 1 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 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Diabetes Complications (time frame: Baseline and week 520). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06913153.

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 25 May 2025.