Type 1 DiabetesNCT06791330
Genome-wide Association Study of Different Types of Diabetes and Construction of Genetic Risk Score
An observational study of Type 1 Diabetes, run by Second Xiangya Hospital of Central South University.
Trial summary
To enhance the genetic profile of T1D patients in China and construct a Chinese-specific GRS and evaluated its ability to differentiate between T1D and controls, as well as between T1D and T2D. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Type 1 Diabetes
- Type of treatment
- Pill or oral medicine
- How many people
- 7,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects in these three groups were matched by age and sex.
Who may be able to join
- All diagnoses for diabetes were required to adhere to the 1999 World Health Organization diabetes diagnosis criteria. Type 1 diabetes mellitus patients needed to meet specific criteria, including insulin dependence in the first 6 months and the presence of at least one designated islet autoantibody: glutamic acid decarboxylase antibody (GADA), protein tyrosine phosphatase antibody (IA-2A) and zinc transporter 8 antibody (ZnT8A). Type 2 diabetes mellitus patients also needed to show negative results for all three islet autoantibodies at onset. Controls were defined as individuals without diabetes or a family history of diabetes within the same geographic area who had normal oral glucose tolerance test results.
Who cannot join
- Subjects with the following conditions were excluded: severe gastrointestinal, cardiovascular, cerebrovascular, liver or kidney diseases; other autoimmune diseases; a history of gastrointestinal surgery; tumours; pregnancy; treatments with oral hypoglycaemic agents or immunomodulators; and use of probiotics, prebiotics or antibiotics within one month.
About this study
Official title: A Type 1 Diabetes Genetic Risk Score Discriminates Between Type 1 Diabetes and Type 2 Diabetes in Chinese
To enhance the genetic profile of T1D patients in China and construct a Chinese-specific GRS and evaluated its ability to differentiate between T1D and controls, as well as between T1D and T2D.
Read the detailed description
Type 1 diabetes (T1D) is caused by autoimmune destruction of pancreatic beta cells, leading to severe insulin deficiency and requires life-long insulin therapy. Although traditionally viewed as a disease primarily affecting children and adolescents, recent epidemiological studies have demonstrated that over half of all new-onset T1D cases worldwide occur in adults. At present, methods to differentiate adult-onset T1D from T2D rely on the clinical phenotypes such as onset age and pattern, body mass index (BMI), C-peptide levels, and islet autoantibodies. However, the increasing rates of obesity in T1D, the presence of ketosis-prone T2D and idiopathic T1D, as well as unavailable autoantibody detection in some districts make it an increasing difficult challenge to accurately classify between adult-onset T1D and T2D. The discrimination of diabetes types is more challenging in the Chinese population due to the higher prevalence of early-onset T2D at a lower BMI than in European populations. Incorrectly identifying T1D as T2D can result in inadequate control of blood glucose levels, an elevated risk of ketoacidosis, and potentially severe and life-endangering complications. Therefore, it is crucial to search for new discriminative methods for different types of diabetes.
The genetic pathogenesis of T1D and T2D differ significantly, allowing for the differentiation of diabetes types based on genetic information. A T1D genetic risk score (GRS), comprising 31 HLA and non-HLA T1D-associated single nucleotide polymorphisms (SNPs), can be a useful tool to aid the discrimination between T1D and T2D. GRS2, which improved SNP capture of HLA DR-DQ risk including haplotype interactions and added non-DR-DQ loci, showed better discriminative power for the classification of diabetes type among multiethnic youth.
In this study, we employed GWAS to enhance the genetic profile of T1D patients in China. Additionally, our aim was to identify SNP tags for the HLA DR-DQ risk in the Chinese population, which could capture HLA DR-DQ risk and the interactions between these haplotypes. Using this information, we constructed a Chinese-specific GRS and evaluated its ability to differentiate between T1D and controls, as well as between T1D and T2D.
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, genetic risk score, genome-wide association study, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Genetic Risk Score, Diabetes Mellitus, Type 2
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 were defined as individuals without diabetes or a family history of diabetes within the same geographic area who had normal oral glucose tolerance test results | |
| Type 1 diabetes | All diagnoses for diabetes were required to adhere to the 1999 World Health Organization diabetes diagnosis criteria. Type 1 diabetes mellitus patients needed to meet specific criteria, including insulin dependence in the first 6 months and the presence of at least one designated islet autoantibody: glutamic acid decarboxylase antibody (GADA), protein tyrosine phosphatase antibody (IA-2A) and zinc transporter 8 antibody (ZnT8A). | |
| Type 2 diabetes | All diagnoses for diabetes were required to adhere to the 1999 World Health Organization diabetes diagnosis criteria. Type 2 diabetes mellitus patients also needed to show negative results for all three islet autoantibodies at onset, including glutamic acid decarboxylase antibody (GADA), protein tyrosine phosphatase antibody (IA-2A) and zinc transporter 8 antibody (ZnT8A). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identified single nucleotide polymorphisms that reach genome-wide significance
Single nucleotide polymorphisms should reach the genome-wide significance，which is defined as a P value of smaller than 5e-8.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study startJan 2010
- Primary completionApr 2024
- Study completionApr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 7,000 participants (actual)
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
- NCT06791330
- Sponsor's protocol ID
- 2019GRS
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Type 1 Diabetes Genetic Risk Score Discriminates Between Type 1 Diabetes and Type 2 Diabetes in Chinese
- ClinicalTrials.gov ID
- NCT06791330
- Acronym / sponsor ID
- 2019GRS
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, genetic risk score, genome-wide association study, type 2 diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Apr 2024 (actual)
- Study completion
- Apr 2024 (actual)
- First posted
- 24 Jan 2025 (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 enhance the genetic profile of T1D patients in China and construct a Chinese-specific GRS and evaluated its ability to differentiate between T1D and controls, as well as between T1D and T2D.
Detailed description
Type 1 diabetes (T1D) is caused by autoimmune destruction of pancreatic beta cells, leading to severe insulin deficiency and requires life-long insulin therapy. Although traditionally viewed as a disease primarily affecting children and adolescents, recent epidemiological studies have demonstrated that over half of all new-onset T1D cases worldwide occur in adults. At present, methods to differentiate adult-onset T1D from T2D rely on the clinical phenotypes such as onset age and pattern, body mass index (BMI), C-peptide levels, and islet autoantibodies. However, the increasing rates of obesity in T1D, the presence of ketosis-prone T2D and idiopathic T1D, as well as unavailable autoantibody detection in some districts make it an increasing difficult challenge to accurately classify between adult-onset T1D and T2D. The discrimination of diabetes types is more challenging in the Chinese population due to the higher prevalence of early-onset T2D at a lower BMI than in European populations. Incorrectly identifying T1D as T2D can result in inadequate control of blood glucose levels, an elevated risk of ketoacidosis, and potentially severe and life-endangering complications. Therefore, it is crucial to search for new discriminative methods for different types of diabetes.
The genetic pathogenesis of T1D and T2D differ significantly, allowing for the differentiation of diabetes types based on genetic information. A T1D genetic risk score (GRS), comprising 31 HLA and non-HLA T1D-associated single nucleotide polymorphisms (SNPs), can be a useful tool to aid the discrimination between T1D and T2D. GRS2, which improved SNP capture of HLA DR-DQ risk including haplotype interactions and added non-DR-DQ loci, showed better discriminative power for the classification of diabetes type among multiethnic youth.
In this study, we employed GWAS to enhance the genetic profile of T1D patients in China. Additionally, our aim was to identify SNP tags for the HLA DR-DQ risk in the Chinese population, which could capture HLA DR-DQ risk and the interactions between these haplotypes. Using this information, we constructed a Chinese-specific GRS and evaluated its ability to differentiate between T1D and controls, as well as between T1D and T2D.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Controls were defined as individuals without diabetes or a family history of diabetes within the same geographic area who had normal oral glucose tolerance test results |
| Type 1 diabetes | – | –All diagnoses for diabetes were required to adhere to the 1999 World Health Organization diabetes diagnosis criteria. Type 1 diabetes mellitus patients needed to meet specific criteria, including insulin dependence in the first 6 months and the presence of at least one designated islet autoantibody: glutamic acid decarboxylase antibody (GADA), protein tyrosine phosphatase antibody (IA-2A) and zinc transporter 8 antibody (ZnT8A). |
| Type 2 diabetes | – | –All diagnoses for diabetes were required to adhere to the 1999 World Health Organization diabetes diagnosis criteria. Type 2 diabetes mellitus patients also needed to show negative results for all three islet autoantibodies at onset, including glutamic acid decarboxylase antibody (GADA), protein tyrosine phosphatase antibody (IA-2A) and zinc transporter 8 antibody (ZnT8A). |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects in these three groups were matched by age and sex.
Key inclusion criteria (1 listed)
- All diagnoses for diabetes were required to adhere to the 1999 World Health Organization diabetes diagnosis criteria. Type 1 diabetes mellitus patients needed to meet specific criteria, including insulin dependence in the first 6 months and the presence of at least one designated islet autoantibody: glutamic acid decarboxylase antibody (GADA), protein tyrosine phosphatase antibody (IA-2A) and zinc transporter 8 antibody (ZnT8A). Type 2 diabetes mellitus patients also needed to show negative results for all three islet autoantibodies at onset. Controls were defined as individuals without diabetes or a family history of diabetes within the same geographic area who had normal oral glucose tolerance test results.
Key exclusion criteria (1 listed)
- Subjects with the following conditions were excluded: severe gastrointestinal, cardiovascular, cerebrovascular, liver or kidney diseases; other autoimmune diseases; a history of gastrointestinal surgery; tumours; pregnancy; treatments with oral hypoglycaemic agents or immunomodulators; and use of probiotics, prebiotics or antibiotics within one month.
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
Identified single nucleotide polymorphisms that reach genome-wide significance
Time frame: at baseline
Single nucleotide polymorphisms should reach the genome-wide significance，which is defined as a P value of smaller than 5e-8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Second Xiangya Hospital of Central South University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identified single nucleotide polymorphisms that reach genome-wide significance (time frame: at baseline). 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 24 Jan 2025.