Diabetes Mellitus, Type 1NCT05593081
Multicenter Study of Fulminant Type 1 Diabetes in China
An observational study of Diabetes Mellitus, Type 1, run by Second Xiangya Hospital of Central South University at 10 sites in China.
Trial summary
This study took FT1D（fulminant type 1 diabetes） as the research object, collected the cases of FT1D patients, and described the clinical characteristics of this type of disease. The HLA susceptibility genes of FT1D were identified by PCR and other techniques, taking age-sex-matched healthy subjects as controls and HLA… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- HLA
- How many people
- 240 participants
- Where
- 10 sitesChina
- Study dates
- 20 May 2022to 31 Dec 2027
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with fulminant 1 diabetes
Who may be able to join
- 1) diabetic ketosis or ketoacidosis occurred soon after the onset of hyperglycemic symptoms; 2) patient presented with plasma glucose ≥16.0 mmol/L and HbA1c <8.7% at the first visit; and 3) patient had urinary C-peptide excretion <10 µg/day,fasting serum C-peptide level <0.10 nmol/L, or postprandial serum C-peptide <0.17 nmol/L at onset
- Normal control: The inclusion criteria are as follows: (1) Oral glucose tolerance test (OGTT): fasting blood glucose (FPG) <5.6 mmol/L and postprandial 2 h blood glucose (PPG) <7.8 mmol/L. The participants voluntarily signed the informed consent and extracted 3ml of peripheral blood for DNA extraction.
Who cannot join
- Case reports of previously diagnosed with diabetes were excluded.
- Healthy Volunteers
- The exclusion criteria were as follows: (1) with heart, brain, liver, kidney or other chronic diseases; (2) with other types of autoimmune diseases; (3) with malignant tumors; (4) with a family history of diabetes.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
shuoming luo, MD contact
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Changsha Central Hospital
Changsha, Hunan, 4100011
sha liu
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, 4100011
Shuoming Luo, MD
13875936536, shuomingluo@csu.edu.cn
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
xiaoyan chen
- Recruiting
Hainan Provincial People's Hospital
Haikou, Hainan
huibiao quan
- Recruiting
Yunnan Provincial People's Hospital
Kunming, Yunnan
heng su
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
zhifen yang
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
zuojie luo
- Recruiting
Quanzhou First People's Hospital
Quanzhou, Fujian
yi zhang, MD
- Recruiting
Yancheng Third People's Hospital
Yancheng, Jiangs
lei yuan
- Recruiting
Guizhou Provincial People's Hospital
Zunyi, Guangzhou
jianhua luo
About this study
This study took FT1D（fulminant type 1 diabetes） as the research object, collected the cases of FT1D patients, and described the clinical characteristics of this type of disease. The HLA susceptibility genes of FT1D were identified by PCR and other techniques, taking age-sex-matched healthy subjects as controls and HLA genes as the research entry point.
Read the detailed description
- FT1D cases related to different etiologies were collected. The collected case data were the clinical data at the time of hospitalization for the first episode of FT1D, including the history of present illness, past history, vital signs, blood glucose at the onset, blood gas analysis, myocardial enzymes, pancreatic enzymes, glycosylated hemoglobin, C Peptides, islet autoantibodies and other laboratory indicators. Analysis and research are carried out according to factors such as the pathogenesis of the patients, so as to conduct a complete analysis of the pathogenesis characteristics of such patients under the condition of expanding cases, so as to improve the understanding of the disease and the level of diagnosis and treatment of the disease.
- The study collected 240 patients in the FT1D group and 250 patients in the control group with genetic blood (previous research has been available), analyzed the HLA gene, and compared the risk and frequency of HLA class II alleles, genotypes and haplotypes between the two groups. , to explore the susceptibility risk genes and protective properties of Chinese FT1D patients. According to GADA positive and negative, the comparison of the susceptibility of Chinese FT1D class II HLA genotype, from the perspective of genetics to explore the role of antibodies in the pathogenesis of FT1D.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- HLA
- Keywords
- type 1 diabetes: HLA ; fulminant
- 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.
HLAGenetic
Distinguish based on clinical features
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum hemoglobin A1c level
A1c reflects the average blood glucose level
Measured: Every year for up to 5 years
Secondary outcomes (3)
Change in titer of autoantibodies
Glutamic acid decarboxylase antibody
Measured: Every year for up to 5 years
Treatment options
Insulin use protocol and total amount
Measured: Every year for up to 5 years
The incidence of chronic complications of diabetes mellitus
The incidence of diabetic neuropathy, diabetic nephropathy and diabetic retinopathy
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start20 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 240 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguang Zhou, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593081
- Sponsor's protocol ID
- F1 China
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 25 Oct 2022
- 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 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Fulminant Type 1 Diabetes in China
- ClinicalTrials.gov ID
- NCT05593081
- Acronym / sponsor ID
- F1 China
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- type 1 diabetes: HLA ; fulminant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Oct 2022 (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.
This study took FT1D（fulminant type 1 diabetes） as the research object, collected the cases of FT1D patients, and described the clinical characteristics of this type of disease. The HLA susceptibility genes of FT1D were identified by PCR and other techniques, taking age-sex-matched healthy subjects as controls and HLA genes as the research entry point.
Detailed description
- FT1D cases related to different etiologies were collected. The collected case data were the clinical data at the time of hospitalization for the first episode of FT1D, including the history of present illness, past history, vital signs, blood glucose at the onset, blood gas analysis, myocardial enzymes, pancreatic enzymes, glycosylated hemoglobin, C Peptides, islet autoantibodies and other laboratory indicators. Analysis and research are carried out according to factors such as the pathogenesis of the patients, so as to conduct a complete analysis of the pathogenesis characteristics of such patients under the condition of expanding cases, so as to improve the understanding of the disease and the level of diagnosis and treatment of the disease.
- The study collected 240 patients in the FT1D group and 250 patients in the control group with genetic blood (previous research has been available), analyzed the HLA gene, and compared the risk and frequency of HLA class II alleles, genotypes and haplotypes between the two groups. , to explore the susceptibility risk genes and protective properties of Chinese FT1D patients. According to GADA positive and negative, the comparison of the susceptibility of Chinese FT1D class II HLA genotype, from the perspective of genetics to explore the role of antibodies in the pathogenesis of FT1D.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with fulminant 1 diabetes
Key inclusion criteria (2 listed)
- 1) diabetic ketosis or ketoacidosis occurred soon after the onset of hyperglycemic symptoms; 2) patient presented with plasma glucose ≥16.0 mmol/L and HbA1c <8.7% at the first visit; and 3) patient had urinary C-peptide excretion <10 µg/day,fasting serum C-peptide level <0.10 nmol/L, or postprandial serum C-peptide <0.17 nmol/L at onset
- Normal control: The inclusion criteria are as follows: (1) Oral glucose tolerance test (OGTT): fasting blood glucose (FPG) <5.6 mmol/L and postprandial 2 h blood glucose (PPG) <7.8 mmol/L. The participants voluntarily signed the informed consent and extracted 3ml of peripheral blood for DNA extraction.
Key exclusion criteria (3 listed)
- Case reports of previously diagnosed with diabetes were excluded.
- Healthy Volunteers
- The exclusion criteria were as follows: (1) with heart, brain, liver, kidney or other chronic diseases; (2) with other types of autoimmune diseases; (3) with malignant tumors; (4) with a family history of diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLADistinguish based on clinical features | Genetic | – |
Primary outcome
Change in serum hemoglobin A1c level
Time frame: Every year for up to 5 years
A1c reflects the average blood glucose level
3 secondary outcomes
Change in titer of autoantibodies
Time frame: Every year for up to 5 years
Treatment options
Time frame: Every year for up to 5 years
The incidence of chronic complications of diabetes mellitus
Time frame: up to 5 years
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 25 Oct 2022.
- 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.
shuoming luo, MD contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Second Xiangya Hospital of Central South University at 10 sites 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 2 inclusion and 3 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 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 zhiguang zhou, MD (+8673185292154, zhouzhiguang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum hemoglobin A1c level (time frame: Every year for up to 5 years). 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 25 Oct 2022.