Multicenter Study of Fulminant Type 1 Diabetes in China
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- NCT05593081
- Lead Sponsor
- Second Xiangya Hospital of Central South University
- Brief 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in serum hemoglobin A1c level Every year for up to 5 years A1c reflects the average blood glucose level
- Secondary Outcome Measures
Name Time Method The incidence of chronic complications of diabetes mellitus up to 5 years The incidence of diabetic neuropathy, diabetic nephropathy and diabetic retinopathy
Change in titer of autoantibodies Every year for up to 5 years Glutamic acid decarboxylase antibody
Treatment options Every year for up to 5 years Insulin use protocol and total amount
Trial Locations
- Locations (10)
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Yancheng Third People's Hospital
🇨🇳Yancheng, Jiangs, China
Yunnan Provincial People's Hospital
🇨🇳Kunming, Yunnan, China
Quanzhou First People's Hospital
🇨🇳Quanzhou, Fujian, China
Hainan Provincial People's Hospital
🇨🇳Haikou, Hainan, China
Changsha Central Hospital
🇨🇳Changsha, Hunan, China
Guizhou Provincial People's Hospital
🇨🇳Zunyi, Guangzhou, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, China