Genetic Risk Score for Predicting Insulin Deficiency in People With Diabetes
Studies whether a type 1 diabetes genetic score predicts insulin deficiency in diabetic patients.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Changsha, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 50 years old?
Source: NCT07621445, who can take part
Where in China
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South UniversityChangsha, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Xiangya Hospital of Central South University
- Trial code
- NCT07621445
- Record updated
- 2 June 2026
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Those who have been under long-term treatment with hormones or immunosuppressants; Those with concurrent malignant tumors or severe heart, liver, and kidney diseases; 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; 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.