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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Donghui Zhang — Peking University First Hospital
• Study coordinator: Nan Gu
• Email: 13811135033@163.com
• Phone: +8613811135033

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.