Genetic risk score and progression to insulin in 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 multicenter nested case-control study examines whether a genetic risk score can predict progression to insulin deficiency in individuals with type 1 diabetes. Cases are patients who progressed to insulin deficiency or severe insulin deficiency, while controls did not progress to insulin deficiency. The study follows participants for three years to compare genetic characteristics between groups. Eligibility includes newly diagnosed diabetes patients aged 14–50, diagnosed within the last year, with specific glucose or HbA1c criteria; certain conditions and treatments exclude participation. Interventions are observational, focusing on collecting observational indicators rather than administering treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Gender is not restricted.
* Age ranges from 14 to 50 years old.
* Diagnosis of diabetes within \< 1 year:

  1. If there are diabetes symptoms and meet any of the following criteria:① Plasma glucose at any time ≥ 11.1 mmol/L (200 mg/dL), or② Fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL), or③ Plasma glucose 2 hours after OGTT/post - meal ≥ 11.1 mmol/L (200 mg/dL), or④ HbA1c ≥ 6.5%.
  2. If there are no diabetes symptoms, another test on a different day is required for diagnosis.
* Newly - diagnosed diabetes patients whose type diagnosis is considered unclear clinically.

Exclusion Criteria:

* Peak C-peptide \< 200 pmol/L;
* Gestational diabetes, monogenic diabetes (neonatal diabetes, MODY), exocrine pancreatic diseases (cystic fibrosis), diabetes caused by drugs or chemicals;
* Those who have been under long-term treatment with hormones or immunosuppressants;
* Pregnant or lactating women;
* Those with concurrent malignant tumors or severe heart, liver, and kidney diseases;
* Those with an expected survival time of less than 3 years;
* Those with mental disorders or unable to cooperate with the investigation for other reasons;
* Acute phase of diabetic ketoacidosis;
* Stress conditions such as severe infection, fever, trauma, and major surgery;
* Patients lacking major clinical information;
* Those considered by the researcher as unfit to participate in this study.

Where it's running

• Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
  Changsha, Hunan, China Recruiting

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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.