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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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; | "baseline"、"third year" |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting and 2 - hour blood glucose | "baseline"、"third year" | |
| Glycosylated hemoglobin | "baseline"、"third year" | |
| Whether insulin treatment is needed |
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Inclusion Criteria:
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.
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410011 | China |
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Collect the medical history and current medication information of the subjects. |
| "baseline"、"third year" |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D000096442 | Genetic Risk Score |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020022 | Genetic Predisposition to Disease |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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