Environmental Determinants of Type 1 Diabetes Risk
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-70
SponsorSecond Xiangya Hospital of Central South University
About this trial
To analyze the environmental risk factors for type 1 diabetes in China.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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);
Disqualifiers
Individuals with type 1 diabetes
Gestational diabetes.
Confirmed monogenic diabetes.
Secondary diabetes.
Trial population
Individuals with type 1 diabetes, first-degree relatives of individuals with type 1 diabetes, and controls recruited from 18 provinces in China.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
11,240 Participants
are grouped into 3 trial groupsGroup A: Controls
Group B: FDR
Group C: T1D
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 1 year after enrollment2
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.
Time frame
Baseline to 1 year after enrollmentSecondary outcomes
1
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.
Time frame
Baseline to 1 year after enrollment2
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.
Time frame
Baseline to 1 year after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov