Early-Onset Type 2 DiabetesNCT07307040
Precision Diabetes Management: Integrated East-West Approach
An observational study of Early-Onset Type 2 Diabetes, run by Peking Union Medical College Hospital.
Trial summary
This project will leverage a large-scale cohort of early-onset type 2 diabetes patients to conduct innovative prospective clinical research. By integrating traditional Chinese medicine diagnostic information, clinical data, laboratory results, continuous glucose monitoring, genetic information, multi-omics data, and… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Early-Onset Type 2 Diabetes
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- Adult
Study population: The age at type 2 diabetes diagnosis is ≥18 years but <40 years.
Who may be able to join
- The age at diabetes diagnosis is ≥18 years but <40 years.
Who cannot join
- The clinical diagnosis was type 1 diabetes, and at the time of enrollment, antibody levels or insulin/C-peptide results still supported the original diagnosis.
- There were clear secondary factors contributing to hyperglycemia, such as Cushing's syndrome or pheochromocytoma.
About this study
Official title: Construction of a Precision and Individualized Management Model for Diabetes With Integrated Traditional Chinese and Western Medicine
This project will leverage a large-scale cohort of early-onset type 2 diabetes patients to conduct innovative prospective clinical research. By integrating traditional Chinese medicine diagnostic information, clinical data, laboratory results, continuous glucose monitoring, genetic information, multi-omics data, and multi-modal monitoring data, and utilizing advanced data analysis methods such as deep learning, the project aims to establish a comprehensive monitoring, precise classification, and personalized diagnosis and treatment model-a holistic management approach integrating traditional Chinese and Western medicine for early-onset type 2 diabetes. This initiative is expected to enhance the management of early-onset type 2 diabetes, improve treatment outcomes and quality of life for affected patients, pioneer an innovative path for personalized integrated traditional Chinese and Western medicine management in this population, and promote the application of precision medicine in diabetes prevention and treatment.
- Conditions
- Early-Onset Type 2 Diabetes
- Being tested
- No interventions
- Keywords
- Integrated Traditional Chinese and Western Medicine, Precision Management, Personalized Management, Early-Onset Type 2 Diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| Integrated Traditional Chinese and Western Medicine Management | Not described Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traditional Chinese Medicine Syndrome Score
Measured: Through study completion, an average of 3 months
HbA1c
Measured: Through study completion, an average of 3 months
Secondary outcomes (5)
Triglycerides
Measured: Through study completion, an average of 3 months
High-Density Lipoprotein Cholesterol
Measured: Through study completion, an average of 3 months
Total Cholesterol
Measured: Through study completion, an average of 3 months
Fasting Blood Glucose
Measured: Through study completion, an average of 3 months
Low-Density Lipoprotein Cholesterol
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start31 Dec 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Onset Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinhua Xiao, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307040
- Sponsor's protocol ID
- CXZH2024059
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Precision and Individualized Management Model for Diabetes With Integrated Traditional Chinese and Western Medicine
- ClinicalTrials.gov ID
- NCT07307040
- Acronym / sponsor ID
- CXZH2024059
- Conditions
- Early-Onset Type 2 Diabetes
- Keywords
- Integrated Traditional Chinese and Western Medicine, Precision Management, Personalized Management, Early-Onset Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 Dec 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.
This project will leverage a large-scale cohort of early-onset type 2 diabetes patients to conduct innovative prospective clinical research. By integrating traditional Chinese medicine diagnostic information, clinical data, laboratory results, continuous glucose monitoring, genetic information, multi-omics data, and multi-modal monitoring data, and utilizing advanced data analysis methods such as deep learning, the project aims to establish a comprehensive monitoring, precise classification, and personalized diagnosis and treatment model-a holistic management approach integrating traditional Chinese and Western medicine for early-onset type 2 diabetes. This initiative is expected to enhance the management of early-onset type 2 diabetes, improve treatment outcomes and quality of life for affected patients, pioneer an innovative path for personalized integrated traditional Chinese and Western medicine management in this population, and promote the application of precision medicine in diabetes prevention and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated Traditional Chinese and Western Medicine Management | – | Other: No interventions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- The age at type 2 diabetes diagnosis is ≥18 years but <40 years.
Key inclusion criteria (1 listed)
- The age at diabetes diagnosis is ≥18 years but <40 years.
Key exclusion criteria (2 listed)
- The clinical diagnosis was type 1 diabetes, and at the time of enrollment, antibody levels or insulin/C-peptide results still supported the original diagnosis.
- There were clear secondary factors contributing to hyperglycemia, such as Cushing's syndrome or pheochromocytoma.
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 |
|---|---|---|
| No interventionsNo interventions | Other | Integrated Traditional Chinese and Western Medicine Management |
Primary outcome
Traditional Chinese Medicine Syndrome Score
Time frame: Through study completion, an average of 3 months
HbA1c
Time frame: Through study completion, an average of 3 months
5 secondary outcomes
Triglycerides
Time frame: Through study completion, an average of 3 months
High-Density Lipoprotein Cholesterol
Time frame: Through study completion, an average of 3 months
Total Cholesterol
Time frame: Through study completion, an average of 3 months
Fasting Blood Glucose
Time frame: Through study completion, an average of 3 months
Low-Density Lipoprotein Cholesterol
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 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.
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 Early-Onset Type 2 Diabetes, run by Peking Union Medical College Hospital.
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 2 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: opening soon, as of the sponsor's last update on 29 Dec 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?
This study is still under way. Results are not available in the source record yet.
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?
Traditional Chinese Medicine Syndrome Score (time frame: Through study completion, an average of 3 months). The study lists 2 primary outcomes in all. 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 29 Dec 2025.