Multicenter Study of Fulminant Type 1 Diabetes in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HLA.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
1. 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. 2. 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.
Interventions
- Genetic HLA
Distinguish based on clinical features
Primary outcome measures
- Change in serum hemoglobin A1c level [Time frame: Every year for up to 5 years]
Secondary outcome measures (3)
- 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]
Eligibility criteria
patients with fulminant 1 diabetes
Inclusion criteria
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
Exclusion criteria
Case reports of previously diagnosed with diabetes were excluded.
Healthy Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
China · 10 centers
- Quanzhou First People's Hospital — Quanzhou
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
- The First Affiliated Hospital of Guangxi Medical University — Nanning
- Guizhou Provincial People's Hospital — Zunyi
- Hainan Provincial People's Hospital — Haikou
- Changsha Central Hospital — Changsha
- Yancheng Third People's Hospital — Yancheng
- The First Affiliated Hospital of Nanchang University — Nanchang
- … and 2 more centers
Identifiers
NCT: NCT05593081 · F1 China