Establishment of Screening Pathway for High-Risk Population of Type 1 Diabetes

NCT07468474 | Recruiting DMC

• 1 other identifier: 2024-487-001
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Interventions

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.

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may not qualify if:

• 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.
• ① Non-type 1 diabetic patients;
• Severe microvascular complications: proliferative retinopathy; Urinary albumin/urinary creatinine \> 300mg/g, or 24-hour urinary protein quantity \> 1g/d; Uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy; ③ Patients who had acute cerebrovascular accident, acute coronary syndrome, peripheral artery disease requiring hospitalization or underwent vascular intervention or amputation within 3 months before enrollment; Blood pressure is consistently higher than 180/110mmHg and cannot be controlled within 160/110mmHg within 1 week; Serum creatinine clearance was less than 30ml/min/1.73m2(calculated according to CKDEPI formula), alanine aminotransferase ≥3 times the upper limit of normal, total bilirubin ≥2 times the upper limit of normal for more than 1 week;
• (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;
• First-degree relatives of patients with type 1 diabetes (including parents, children, siblings);
• Age ≥4 years old; ③ Able and willing to undergo regular outpatient follow-up; ④ Volunteer to participate in the study and sign informed consent.
• Type 1 diabetes has been diagnosed;
• Age ≥40 years old;
• No history of diabetes; ③ Fasting blood glucose \< 6.1mmol/L, 2-hour glucose load blood glucose \< 7.8mmol /L, glycosylated hemoglobin \< 5.7%; ④ Volunteer to participate in the study and sign informed consent.
• ①A definite diagnosis of type 1 diabetes in a first - or second-degree relative.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Donghui Zhang

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Nan Gu

  Peking University First Hospital

  STUDY CHAIR

Central Study Contacts

Nan Gu

CONTACT

+8613811135033; 13811135033@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: March 12, 2026
• Study Start: September 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2025-11

Locations

CN (1)