Type 1 Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
1. For patients with type 1 diabetes, the intervention includes two aspects: Firstly, at the time of subject enrollment, a 12-hour structured course is conducted, covering various aspects such as diabetes diet, exercise, blood sugar monitoring, insulin injection, complication prevention, and psychological adjustment. Secondly, regular outpatient follow-ups are carried out, with a frequency of once every 3 months. The follow-up content includes routine outpatient visit-related items, such as blood sugar, islet function, liver and kidney function, blood lipid, etc., as well as screening for diabetes complications. Follow-ups are conducted regularly based on the time of type 1 diabetes diagnosis. 2. For the first-degree relatives of patients with type 1 diabetes: At the time of subject enrollment, blood samples are taken for genetic polymorphism testing, islet-related autoantibody determination, blood sugar, glycosylated hemoglobin, and islet function assessment; urine samples are collected for urine proteomics determination. Stool samples are collected for stool intestinal flora determination. Subsequently, follow-ups are conducted once a year, with blood sampling and collection of urine and stool samples for the same items as in the baseline follow-up. 3. For healthy control populations, no follow-up arrangements are made. At the time of subject enrollment, blood samples are taken for genetic polymorphism testing, islet-related autoantibody determination, blood sugar, glycosylated hemoglobin, and islet function assessment; urine samples are collected for urine proteomics determination. Stool samples are collected for stool intestinal flora determination.
Interventions
GENETICGene polymorphic detection
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.
Sponsors
Peking University First Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion and
Exclusion criteria
for patients with type 1 diabetes: Inclusion criteria: * Meet the WHO's diabetes diagnostic criteria, diagnosed as type 1 diabetes; ② Able and willing to participate in 12 hours of structured education training; * Able and willing to undergo regular outpatient follow-up; * Volunteer to participate in the study and sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1c in patients with type 1 diabetes | From enrollment to the end of the study at 1,2,3,4 years | Changes in HbA1c in patients with type 1 diabetes at baseline and at 1, 2, 3, and 4 years of follow-up |
| Ther differences in Albumin-to-Creatinine Ratio between type 1 diabetic patients and first-degree relatives and healthy control | From enrollment to the end of the study at 1,2,3,4 years | Albumin-to-Creatinine Ratio will be test in all of the participants |
| Ther differences in Genotype polymorphisms between type 1 diabetic patients and first-degree relatives and healthy control | From enrollment to the end of the study at 1,2,3,4 years | Blood monitoring to assess genetic polymorphisms in all of the participants |
| To establish screening and management paths for high-risk groups of type 1 diabetes patients | up to 4 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in disease self-management scores of patients with type 1 diabetes | From enrollment to the end of the study at 1,2,3,4 years | 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. |
| Changes of quality of life scores in patients with type 1 diabetes | From enrollment to the end of the study at 1,2,3,4 years | 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. |
| Changes of mood scale scores in patients with type 1 diabetes | From enrollment to the end of the study at 1,2,3,4 years | use Beck Depression Inventory Scale to evaluate, the minimum value is 0, and the maximum value is 63, lower scores mean a better outcome. |
| The decline in C-peptide levels in patients with type 1 diabetes | From enrollment to the end of the study at 1,2,3,4 years | the blood C-peptide will be test at baseline and at 1, 2, 3, and 4 years of follow-up |
Countries
China
Contacts
CONTACTNan Gu
PRINCIPAL_INVESTIGATORDonghui Zhang
Peking University First Hospital
STUDY_CHAIRNan Gu
Peking University First Hospital
Outcome results
None listed