Diabetes MellitusNCT07621445
Genetic Risk Score of Type 1 Diabetes Mellitus for Progression to Insulin in Diabetic Patients Lack of Predictive Value: a Multicenter Nested Case-control Study
An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the predictive value of the genetic risk score for type 1 diabetes in the progression to insulin deficiency in diabetic patients. The main question it aims to answer is: 1. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 1
- How many people
- 2,950 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2025to 31 Dec 2029
- 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 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will enroll newly-diagnosed diabetic patients whose clinical subtype is unclear. Participants must be aged between 14 and 50 years, with a diabetes diagnosis within the past year, confirmed by standard American Diabetes Association (ADA) criteria. A key pathophysiological criterion is a peak C-peptide level < 200 pmol/L, suggesting impaired insulin secretion. Key Exclusion Criteria: Patients will be excluded for conditions that could confound the etiology of diabetes or pose additional risks, including: Specific diabetes subtypes (e.g., gestational diabetes, monogenic diabetes, pancreatic diseases). Comorbidities such as malignant tumors or severe organ dysfunction. Acute metabolic derangements (e.g., ketoacidosis). Conditions limiting life expectancy or ability to participate (e.g., expected survival < 3 years, psychiatric disorders). Current pregnancy or lactation.
Who may be able to join
- Gender is not restricted.
- Age ranges from 14 to 50 years old.
- Diagnosis of diabetes within < 1 year:
- If there are diabetes symptoms and meet any of the following criteria:① Plasma glucose at any time ≥ 11.1 mmol/L (200 mg/dL), or② Fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL), or③ Plasma glucose 2 hours after OGTT/post - meal ≥ 11.1 mmol/L (200 mg/dL), or④ HbA1c ≥ 6.5%.
- If there are no diabetes symptoms, another test on a different day is required for diagnosis.
- Newly - diagnosed diabetes patients whose type diagnosis is considered unclear clinically.
Who cannot join
- Peak C-peptide < 200 pmol/L;
- Gestational diabetes, monogenic diabetes (neonatal diabetes, MODY), exocrine pancreatic diseases (cystic fibrosis), diabetes caused by drugs or chemicals;
- Those who have been under long-term treatment with hormones or immunosuppressants;
- Pregnant or lactating women;
- Those with concurrent malignant tumors or severe heart, liver, and kidney diseases;
- Those with an expected survival time of less than 3 years;
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- Those with mental disorders or unable to cooperate with the investigation for other reasons;
- Acute phase of diabetic ketoacidosis;
- Stress conditions such as severe infection, fever, trauma, and major surgery;
- Patients lacking major clinical information;
- Those considered by the researcher as unfit to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
Yang Xiao, MD/PhD, 86-0731-85292154, xiaoyang29@csu.edu.cn
About this study
The goal of this observational study is to evaluate the predictive value of the genetic risk score for type 1 diabetes in the progression to insulin deficiency in diabetic patients. The main question it aims to answer is:
- To investigate the predictive efficacy of the genetic risk score for T1DM in determining whether diabetic patients will progress to insulin deficiency;
- To compare the differences in genetic characteristics between the insulin-deficient cohort and the non-insulin-deficient cohort.
This study is a nested case-control study, in which a case group and a control group are set up for the collection of observational indicators. Case group: Diabetic patients who "progressed to insulin deficiency" and those who "progressed to severe insulin deficiency". Control group: Patients who did not progress to insulin deficiency. The study period is 3 years.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1
- Keywords
- Genetic risk score
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes who 'progress to insulin deficiency and severe insulin deficiency' | Patients with diabetes who 'progress to insulin deficiency' and 'progress to severe insulin deficiency' | |
| Patients who have not progressed to insulin deficiency | For each case, several controls (1:2) were randomly selected from patients in this cohort who had not progressed to insulin deficiency at the same follow - up time point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide
The primary endpoint is the occurrence of progression to insulin deficiency. Subjects who "progress to insulin deficiency" are defined as those whose C-peptide level drops to C-peptide < 250 pmol/L during the follow - up period;
Measured: "baseline"、"third year"
Secondary outcomes (3)
Fasting and 2 - hour blood glucose
Measured: "baseline"、"third year"
Glycosylated hemoglobin
Measured: "baseline"、"third year"
Whether insulin treatment is needed
Collect the medical history and current medication information of the subjects.
Measured: "baseline"、"third year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start27 Oct 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,950 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Xiao, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621445
- Sponsor's protocol ID
- 2025 T1DGRS LYF20250124
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Risk Score of Type 1 Diabetes Mellitus for Progression to Insulin in Diabetic Patients Lack of Predictive Value: a Multicenter Nested Case-control Study
- ClinicalTrials.gov ID
- NCT07621445
- Acronym / sponsor ID
- 2025 T1DGRS LYF20250124
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1
- Keywords
- Genetic risk score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,950 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Jun 2026 (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.
The goal of this observational study is to evaluate the predictive value of the genetic risk score for type 1 diabetes in the progression to insulin deficiency in diabetic patients. The main question it aims to answer is:
- To investigate the predictive efficacy of the genetic risk score for T1DM in determining whether diabetic patients will progress to insulin deficiency;
- To compare the differences in genetic characteristics between the insulin-deficient cohort and the non-insulin-deficient cohort.
This study is a nested case-control study, in which a case group and a control group are set up for the collection of observational indicators. Case group: Diabetic patients who "progressed to insulin deficiency" and those who "progressed to severe insulin deficiency". Control group: Patients who did not progress to insulin deficiency. The study period is 3 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes who 'progress to insulin deficiency and severe insulin deficiency' | – | –Patients with diabetes who 'progress to insulin deficiency' and 'progress to severe insulin deficiency' |
| Patients who have not progressed to insulin deficiency | – | –For each case, several controls (1:2) were randomly selected from patients in this cohort who had not progressed to insulin deficiency at the same follow - up time point. |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will enroll newly-diagnosed diabetic patients whose clinical subtype is unclear. Participants must be aged between 14 and 50 years, with a diabetes diagnosis within the past year, confirmed by standard American Diabetes Association (ADA) criteria. A key pathophysiological criterion is a peak C-peptide level < 200 pmol/L, suggesting impaired insulin secretion. Key Exclusion Criteria: Patients will be excluded for conditions that could confound the etiology of diabetes or pose additional risks, including: Specific diabetes subtypes (e.g., gestational diabetes, monogenic diabetes, pancreatic diseases). Comorbidities such as malignant tumors or severe organ dysfunction. Acute metabolic derangements (e.g., ketoacidosis). Conditions limiting life expectancy or ability to participate (e.g., expected survival < 3 years, psychiatric disorders). Current pregnancy or lactation.
Key inclusion criteria (6 listed)
- Gender is not restricted.
- Age ranges from 14 to 50 years old.
- Diagnosis of diabetes within < 1 year:
- Newly - diagnosed diabetes patients whose type diagnosis is considered unclear clinically.
Key exclusion criteria (11 listed)
- Peak C-peptide < 200 pmol/L;
- Gestational diabetes, monogenic diabetes (neonatal diabetes, MODY), exocrine pancreatic diseases (cystic fibrosis), diabetes caused by drugs or chemicals;
- Those who have been under long-term treatment with hormones or immunosuppressants;
- Pregnant or lactating women;
- Those with concurrent malignant tumors or severe heart, liver, and kidney diseases;
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
C-peptide
Time frame: "baseline"、"third year"
The primary endpoint is the occurrence of progression to insulin deficiency. Subjects who "progress to insulin deficiency" are defined as those whose C-peptide level drops to C-peptide < 250 pmol/L during the follow - up period;
3 secondary outcomes
Fasting and 2 - hour blood glucose
Time frame: "baseline"、"third year"
Glycosylated hemoglobin
Time frame: "baseline"、"third year"
Whether insulin treatment is needed
Time frame: "baseline"、"third year"
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 2 Jun 2026.
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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.
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, China
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 Mellitus and Diabetes Mellitus, Type 1, run by Second Xiangya Hospital of Central South University 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-peptide (time frame: "baseline"、"third year"). 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 2 Jun 2026.