Environmental factors and Type 1 diabetes risk in China

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 observational study aims to explore environmental contributors to type 1 diabetes in China, focusing on genetic and environmental interactions. It will collect data from individuals with Type 1 diabetes, their relatives, and healthy controls to identify potential environmental risk factors such as diet, infections, and other exposures. The study does not involve an intervention and will analyze associations between environment-related variables and disease status. Participants must meet criteria related to age, autoantibody positivity, disease duration, and family relationship to a person with T1D. Results could inform future prevention strategies and risk stratification.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Individuals with type 1 diabetes (no age restriction):

   * Clinically diagnosed with T1D by a specialist.
   * Meeting any one of the following conditions:(1) Age of onset \< 15 years;(2) No overweight or obesity at onset;(3) History of ketoacidosis.
   * Insulin-dependent since disease onset;
   * Positive for at least one islet autoantibody (GADA, IA-2A, ZnT8A, IAA, ICA);
   * Disease duration ≤ 3 years.
2. First-degree relatives:

   * Parents, siblings, or children of an individual with T1D.
   * Age ≤ 45 years.

Exclusion Criteria:

1. Individuals with type 1 diabetes

   * Gestational diabetes.
   * Confirmed monogenic diabetes.
   * Secondary diabetes.
   * Type 2 diabetes.
   * Other specific types of diabetes.
2. First-degree relatives:

   * Diagnosed with diabetes before screening;
   * Previous or current use of glucose-lowering drugs.

Common exclusion criteria:

* Severe active disease or a condition likely to substantially affect life expectancy, including malignancy or severe cardiac, pulmonary, hepatic, or renal disease.
* A condition that may require immunosuppressive therapy during the study period.
* Current systemic immunosuppressive therapy.
* Current systemic glucocorticoid therapy.
* Participation in another drug or medical device trial during recruitment or the study period.
* History of major surgery or severe trauma.

Where it's running

• the Second Xiangya Hospital, central south of university
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Yang Xiao
• Email: xiaoyang29@csu.edu.cn
• Phone: 86-731-85292154

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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.