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Recruiting Observational

Environmental Determinants of Type 1 Diabetes Risk

NCT07835724 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-08-01
Last updated
2026-09-23

Condition(s) studied

Type 1 Diabetes Mellitus (T1DM)Healthy ControlRelatives to/Carers of Patients

Study summary

To analyze the environmental risk factors for type 1 diabetes in China.

Eligibility

Sex
ALL
Min age
3 Years
Max age
70 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Change From Baseline in Fasting C-peptide Concentration at 1 Year — Baseline to 1 year after enrollment
    Fasting C-peptide concentration will be measured at baseline and at 1 year after enrollment. The change from baseline will be calculated as the C-peptide concentration at 1 year minus the baseline concentration and reported in pmol/L.
  • Change From Baseline in 2-Hour Postprandial C-peptide Concentration at 1 Year — Baseline to 1 year after enrollment
    Two-hour postprandial C-peptide concentration will be measured at baseline and at 1 year after enrollment. The change from baseline will be calculated as the 2-hour postprandial C-peptide concentration at 1 year minus the baseline concentration and reported in pmol/L.

Trial sites (1)

FacilityCityRegionStatus
the Second Xiangya Hospital, central south of university Changsha Hunan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07835724 on ClinicalTrials.gov ↗ ← All trials in China