Clinical Trials in China / NCT07835724
Recruiting
Observational
Environmental Determinants of Type 1 Diabetes Risk
NCT07835724 · tracked via the Priya Life Science China tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| the Second Xiangya Hospital, central south of university | Changsha | Hunan | Recruiting |
More Second Xiangya Hospital of Central South University trials in China
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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