Diabetes Mellitus, Diabetes Mellitus, Type 1
Conditions
Keywords
Genetic risk score
Brief 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. 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.
Interventions
None listed
Sponsors
Second Xiangya Hospital of Central South University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Gender is not restricted. * Age ranges from 14 to 50 years old. * Diagnosis of diabetes within \< 1 year: 1. 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%. 2. 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 criteria
* 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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C-peptide | "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; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting and 2 - hour blood glucose | "baseline"、"third year" | — |
| Glycosylated hemoglobin | "baseline"、"third year" | — |
| Whether insulin treatment is needed | "baseline"、"third year" | Collect the medical history and current medication information of the subjects. |
Countries
China
Outcome results
None listed