Actively Recruiting
Establishment of Screening Pathway for High-Risk Population of Type 1 Diabetes
Led by Peking University First Hospital · Updated on 2026-03-12
340
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Establishment of Screening Pathway for High-Risk Population of Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of type 1 diabetes meeting WHO criteria (for T1D patients)
- Willingness and ability to participate in 12 hours of structured education (for T1D patients)
- Willingness and ability to attend regular outpatient follow-ups (for T1D patients and first-degree relatives)
- Volunteering and signing informed consent
- First-degree relatives of type 1 diabetes patients aged 4 years or older
- Healthy controls aged 40 years or older with no history of diabetes and normal blood glucose and HbA1c levels
You will not qualify if you...
- Diagnosis other than type 1 diabetes (for T1D patients)
- Severe diabetic complications such as proliferative retinopathy; urinary albumin/creatinine >300 mg/g; 24-hour urinary protein >1g/day
- Uncontrolled painful diabetic neuropathy or significant autonomic neuropathy
- Recent acute cerebrovascular accident, acute coronary syndrome, peripheral artery disease requiring hospitalization or intervention within 3 months
- Blood pressure consistently above 180/110 mmHg or uncontrolled above 160/110 mmHg within 1 week
- Renal insufficiency (creatinine clearance <30 ml/min/1.73m2), elevated liver enzymes (ALT ≥3 times normal, bilirubin ≥2 times normal for >1 week)
- Use of drugs affecting blood sugar for more than 1 week within 12 weeks prior, except certain low-dose diuretics and thyroid hormones
- Systemic infection, serious concomitant diseases, malignant tumors, chronic diarrhea
- Cognitive dysfunction, mental illness, or inability to cooperate with follow-up
- Type 1 diabetes diagnosis in first-degree relatives (for first-degree relative group)
- Inability to complete regular outpatient follow-up (for first-degree relatives)
- Diagnosis of diabetes or abnormal glucose metabolism in healthy controls
- First- or second-degree relative with definite diagnosis of type 1 diabetes (for healthy controls)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
N
Nan Gu
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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