Type 1 Diabetes Mellitus (T1DM)NCT07835724
Environmental Determinants of Type 1 Diabetes Risk
An observational study of Type 1 Diabetes Mellitus (T1DM) and Healthy Control, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
To analyze the environmental risk factors for type 1 diabetes in China. Read more about this study
- Who is it for?
- Ages 3 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus (T1DM), Healthy Control, Relatives to/Carers of Patients
- How many people
- 11,240 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 1 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals with type 1 diabetes, first-degree relatives of individuals with type 1 diabetes, and controls recruited from 18 provinces in China.
Who may be able to join
- 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.
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- First-degree relatives:
- Parents, siblings, or children of an individual with T1D.
- Age ≤ 45 years.
Who cannot join
- Individuals with type 1 diabetes
- Gestational diabetes.
- Confirmed monogenic diabetes.
- Secondary diabetes.
- Type 2 diabetes.
- Other specific types of diabetes.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Xiangya Hospital, central south of university
Changsha, Hunan, 410011
Yang Xiao, MD/Phd, 13574848588, xiaoyang29@csu.edu.cn
About this study
To analyze the environmental risk factors for type 1 diabetes in China.
Read the detailed description
Type 1 diabetes (T1D) is a hyperglycemic disease caused by absolute insulin deficiency. It has an acute and early onset, and patients require lifelong insulin therapy. Global T1D incidence is rising yearly. China has the fourth-largest number of T1D patients and the second-fastest increase in incidence, with a marked rise in adults. T1D results from genetic and environmental factors that cause immune destruction of pancreatic β cells. Genetic risk is relatively clear: HLA DR4-DQ8 and DR3-DQ2 carry the highest risk, and over 70 related loci have been identified. However, environmental factors remain insufficiently characterized. Studies of migrants, socioeconomic differences, and mobile populations suggest that environment and lifestyle have significant effects. Since China's genetic background has not changed substantially while incidence continues to rise, environment-induced immune dysregulation combined with genetic susceptibility may be key. International cohorts such as TEDDY and DAISY confirm that diet, viral infections, and gut microbiota can trigger islet autoimmunity. Among specific factors, high maternal early-pregnancy BMI, rapid childhood growth, and obesity increase risk; vitamin D is protective, and China's north-high/south-low incidence gradient may relate to sunlight and vitamin D. Gluten may trigger islet autoimmune inflammation via gut microbiota and immune activation. Viral infection, pollution, chemical exposure, and socioeconomic status may also contribute. Most evidence comes from European and American populations, while Chinese studies are limited. Therefore, systematically identifying China-specific environmental risk factors has important scientific and public-health value. In summary, genetics determines susceptibility, while modifiable environmental factors are critical in triggering and progression and are key to early prevention and precision management of T1D.
- Keywords
- type 1 diabetes, environmental factors
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Controls matched to the recruited patients. | |
| FDR | First-degree relatives of patients with type 1 diabetes. | |
| T1D | patients with type 1 diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Fasting C-peptide Concentration at 1 Year
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.
Measured: Baseline to 1 year after enrollment
Change From Baseline in 2-Hour Postprandial C-peptide Concentration at 1 Year
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.
Measured: Baseline to 1 year after enrollment
Secondary outcomes (2)
Serum Islet Autoantibodies seroconversion.
Serum islet autoantibodies, including glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), zinc transporter 8 autoantibody (ZnT8A), and insulin autoantibody (IAA), will be measured at baseline and 1 year after enrollment.
Measured: Baseline to 1 year after enrollment
Change From Baseline in Number of Positive Serum Islet Autoantibodies at 1 Year
Serum islet autoantibodies, including glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), zinc transporter 8 autoantibody (ZnT8A), and insulin autoantibody (IAA), will be measured at baseline and 1 year after enrollment. The number of positive islet autoantibodies will be recorded at each time point, and the change from baseline will be calculated as the number at 1 year minus the number at baseline.
Measured: Baseline to 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Aug 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus (T1DM)Studies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Xiao, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835724
- Sponsor's protocol ID
- EDITER2024
- Other IDs
- 2023ZD0507300
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Determinants of Type 1 Diabetes Risk
- ClinicalTrials.gov ID
- NCT07835724
- Acronym / sponsor ID
- EDITER2024
- Keywords
- type 1 diabetes, environmental factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11,240 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To analyze the environmental risk factors for type 1 diabetes in China.
Detailed description
Type 1 diabetes (T1D) is a hyperglycemic disease caused by absolute insulin deficiency. It has an acute and early onset, and patients require lifelong insulin therapy. Global T1D incidence is rising yearly. China has the fourth-largest number of T1D patients and the second-fastest increase in incidence, with a marked rise in adults. T1D results from genetic and environmental factors that cause immune destruction of pancreatic β cells. Genetic risk is relatively clear: HLA DR4-DQ8 and DR3-DQ2 carry the highest risk, and over 70 related loci have been identified. However, environmental factors remain insufficiently characterized. Studies of migrants, socioeconomic differences, and mobile populations suggest that environment and lifestyle have significant effects. Since China's genetic background has not changed substantially while incidence continues to rise, environment-induced immune dysregulation combined with genetic susceptibility may be key. International cohorts such as TEDDY and DAISY confirm that diet, viral infections, and gut microbiota can trigger islet autoimmunity. Among specific factors, high maternal early-pregnancy BMI, rapid childhood growth, and obesity increase risk; vitamin D is protective, and China's north-high/south-low incidence gradient may relate to sunlight and vitamin D. Gluten may trigger islet autoimmune inflammation via gut microbiota and immune activation. Viral infection, pollution, chemical exposure, and socioeconomic status may also contribute. Most evidence comes from European and American populations, while Chinese studies are limited. Therefore, systematically identifying China-specific environmental risk factors has important scientific and public-health value. In summary, genetics determines susceptibility, while modifiable environmental factors are critical in triggering and progression and are key to early prevention and precision management of T1D.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Controls matched to the recruited patients. |
| FDR | – | –First-degree relatives of patients with type 1 diabetes. |
| T1D | – | –patients with type 1 diabetes |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with type 1 diabetes, first-degree relatives of individuals with type 1 diabetes, and controls recruited from 18 provinces in China.
Key inclusion criteria (9 listed)
- Individuals with type 1 diabetes (no age restriction):
- First-degree relatives:
Key exclusion criteria (16 listed)
- Individuals with type 1 diabetes
- First-degree relatives:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline in Fasting C-peptide Concentration at 1 Year
Time frame: 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
Time frame: 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.
2 secondary outcomes
Serum Islet Autoantibodies seroconversion.
Time frame: Baseline to 1 year after enrollment
Change From Baseline in Number of Positive Serum Islet Autoantibodies at 1 Year
Time frame: Baseline to 1 year after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus (T1DM) and Healthy Control, run by Second Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Xiao (86-731-85292154, xiaoyang29@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Fasting C-peptide Concentration at 1 Year (time frame: Baseline to 1 year after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.