NCT07621445Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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. To investigate the predictive efficacy of the genetic risk score for T1DM in determining whether diabetic patients will progress to insulin deficiency; 2. 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2950 (estimated)
- First submitted
- 9 Feb 2026
- Start date
- 27 Oct 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Diseases
- Type 1 diabetes
- NCT number
- NCT07621445
What you commit to
- Study type: Observational
- Planned participants: 2950
- From 27 Oct 2025 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who have been under long-term treatment with hormones or immunosuppressants;
- Those with concurrent malignant tumors or severe heart, liver, and kidney diseases;
Other illness
- Gestational diabetes, monogenic diabetes (neonatal diabetes, MODY), exocrine pancreatic diseases (cystic fibrosis), diabetes caused by drugs or chemicals;
- Those with mental disorders or unable to cooperate with the investigation for other reasons;
- Stress conditions such as severe infection, fever, trauma, and major surgery;
Other
- Peak C-peptide \< 200 pmol/L;
- Pregnant or lactating women;
- Those with an expected survival time of less than 3 years;
- Acute phase of diabetic ketoacidosis;
- Patients lacking major clinical information;
- Those considered by the researcher as unfit to participate in this study.
Who the study is looking for
- 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.
Age in the registry: 14 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.