Screening and management pathway for people at high risk of type 1 diabetes

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

This project will try regular blood, urine, and stool tests to see if they can identify and guide care for people at high risk of type 1 diabetes, including patients and their close relatives.

Quick facts

• Study type: Observational
• Enrollment: 340 (estimated)
• Ages: 4 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07468474 on ClinicalTrials.gov

What this trial studies

This prospective cohort will enroll 340 participants (150 people with type 1 diabetes, 150 first‑degree relatives, and 40 age- and sex-matched healthy controls) at Peking University First Hospital. Patients will receive a 12‑hour structured education at enrollment and quarterly outpatient follow-ups, while first‑degree relatives will be followed annually for four years; healthy controls provide baseline comparisons only. Annual samples (blood for genetics, islet autoantibodies, glucose, HbA1c and pancreatic function; urine for proteomics; stool for microbiota) will be collected to develop a multi-gene risk score and evaluate the predictive value of islet autoantibodies. The study aims to standardize a screening pathway and combine genetic, serologic, and multi-omics markers to stratify T1D risk and subtypes.

Who should consider this trial

Good fit: Ideal candidates are people diagnosed with type 1 diabetes who can attend the 12‑hour education and quarterly follow-ups, their first‑degree relatives willing to undergo annual testing and sample collection, and healthy age- and sex-matched volunteers for baseline comparison.

Not a fit: People without type 1 diabetes, those with severe uncontrolled complications or recent major cardiovascular events, or individuals unwilling or unable to comply with follow-up and sample collection are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the program could identify people before symptomatic onset and allow earlier monitoring or targeted management to reduce progression or complications.

How similar studies have performed: Previous work has shown islet autoantibodies and genetic risk scores can predict type 1 diabetes risk, so this study builds on established methods while adding urine proteomics and microbiota profiling for a more integrated approach.

Eligibility 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.

   Exclusion criteria:

   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;

⑩ 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);

  * 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.

Exclusion criteria:

* Type 1 diabetes has been diagnosed;

  * Second degree relatives of patients with type 1 diabetes; ③ Patients who could not complete regular outpatient follow-up. (3) Inclusion and exclusion criteria for healthy people:

Inclusion criteria:

* 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.

Exclusion criteria:

①A definite diagnosis of type 1 diabetes in a first - or second-degree relative.

Where this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Donghui Zhang — Peking University First Hospital
• Study coordinator: Nan Gu

Conditions Type 1 Diabetes Mellitus