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This study aims to establish a system for identifying and screening high-risk individuals for type 1 diabetes (T1D) and a standardized management pathway for high-risk individuals. It is a prospective cohort study. We plan to enroll 340 eligible subjects, including 40 healthy controls of the same gender and age, 150 T1D patients, and 150 first-degree relatives of T1D patients. The follow-up visit cycle for T1D patients and their first-degree relatives is 4 years. Blood samples will be collected annually for genetic polymorphism testing, pancreatic islet-related autoantibody measurement, blood glucose, hemoglobin A1c, and pancreatic function assessment. Urine samples will be collected for urine proteomics measurement. Fecal samples will be collected for fecal intestinal microbiota measurement. The value of pancreatic islet autoantibody markers in predicting T1D high-risk individuals will be evaluated, and a multi-gene risk score (PRS) prediction model will be established for subtypes of T1D, including acute and chronic T1D. A comprehensive T1D high-risk individual identification and screening system will be established and promoted for application.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gene polymorphic detection | Genetic | The follow-up visit period of T1D patients and their first-degree relatives was 4 years. Blood samples were collected every year for detection of gene polymorphism, determination of islet related autoantibodies, blood glucose, glycated hemoglobin, and islet function evaluation. Urine samples were collected for urinary proteomic determination. Stool samples were collected for the determination of stool intestinal flora. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c in patients with type 1 diabetes | Changes in HbA1c in patients with type 1 diabetes at baseline and at 1, 2, 3, and 4 years of follow-up | From enrollment to the end of the study at 1,2,3,4 years |
| Ther differences in Albumin-to-Creatinine Ratio between type 1 diabetic patients and first-degree relatives and healthy control | Albumin-to-Creatinine Ratio will be test in all of the participants | From enrollment to the end of the study at 1,2,3,4 years |
| Ther differences in Genotype polymorphisms between type 1 diabetic patients and first-degree relatives and healthy control | Blood monitoring to assess genetic polymorphisms in all of the participants | From enrollment to the end of the study at 1,2,3,4 years |
| To establish screening and management paths for high-risk groups of type 1 diabetes patients | Establish an identification and screening system for high-risk groups of type 1 diabetes, as well as a standardized management pathway for these high-risk groups. | up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in disease self-management scores of patients with type 1 diabetes | use Adult Type 1 Diabetes Self-Management Scale to evaluate, the minimum value is 0, and the maximum value is 120, higher scores mean a better outcome. | From enrollment to the end of the study at 1,2,3,4 years |
| Changes of quality of life scores in patients with type 1 diabetes |
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Inclusion and exclusion criteria for patients with type 1 diabetes:
Inclusion criteria:
Meet the WHO's diabetes diagnostic criteria, diagnosed as type 1 diabetes; â‘¡ Able and willing to participate in 12 hours of structured education training;
Able and willing to undergo regular outpatient follow-up;
Exclusion criteria:
â‘ Non-type 1 diabetic patients;
(6) Have used drugs that may affect blood sugar for more than 1 week within 12 weeks, such as oral/intravenous glucocorticoids, growth hormones, estrogen/progesterone, high-dose diuretics, antipsychotic drugs, etc.; However, small doses of diuretics (hydrochlorothiazide < 25mg/d, indapamide ≤1.5mg/d) for antihypertensive purposes, and physiological dosages of thyroid hormones used for replacement therapy are not subject to this limit; (7) Systemic infection or serious concomitant disease; Patients with malignant tumors or chronic diarrhea; Other circumstances that cause the subjects to be unable to complete the study: such as serious cognitive dysfunction, mental illness, etc.;
⑨ The subject is uncooperative, unable to follow up, or the investigator judges that it may be difficult to complete the investigator;
â‘© Other conditions deemed unsuitable for inclusion by the investigator. The study physician will determine whether you are suitable for the study based on your actual condition and the inclusion and exclusion criteria in the study protocol.
(2) Inclusion and exclusion criteria for first-degree relatives of patients with type 1 diabetes:
Inclusion criteria:
First-degree relatives of patients with type 1 diabetes (including parents, children, siblings);
Exclusion criteria:
Type 1 diabetes has been diagnosed;
Inclusion criteria:
Age ≥40 years old;
Exclusion criteria:
â‘ A definite diagnosis of type 1 diabetes in a first - or second-degree relative.
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It is planned to recruit 340 subjects meeting the inclusion criteria, including 40 healthy controls matching gender and age, 150 patients with T1D, and 150 first-degree relatives of T1D patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Gu | Contact | +8613811135033 | 13811135033@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Donghui Zhang | Peking University First Hospital | Principal Investigator |
| Nan Gu | Peking University First Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Blood specimen
use Diabetes-specific Quality of Life Measurement Scale to evaluate, This scale consists of 3 dimensions, namely satisfaction (15 items, with the lowest score being 15 and the highest score being 75), impact degree (20 items, with the lowest score being 20 and the highest score being 100), and anxiety level (11 items, with the lowest score being 11 and the highest score being 55). the lower scores mean a better outcome. |
| From enrollment to the end of the study at 1,2,3,4 years |
| Changes of mood scale scores in patients with type 1 diabetes | use Beck Depression Inventory Scale to evaluate, the minimum value is 0, and the maximum value is 63, lower scores mean a better outcome. | From enrollment to the end of the study at 1,2,3,4 years |
| The decline in C-peptide levels in patients with type 1 diabetes | the blood C-peptide will be test at baseline and at 1, 2, 3, and 4 years of follow-up | From enrollment to the end of the study at 1,2,3,4 years |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |