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Multicenter Study of Fulminant Type 1 Diabetes in China
NCT05593081 · Second Xiangya Hospital of Central South University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
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.
Study design
Enrollment target: 240 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2022-05-20
Estimated completion: 2027-12-31
Last updated: 2022-10-25
Interventions
Genetic: HLA
Primary outcomes
- • Change in serum hemoglobin A1c level (Every year for up to 5 years)
Sponsor
Second Xiangya Hospital of Central South University · other
Contacts & investigators
Contactzhiguang zhou, MD · contact · zhouzhiguang@csu.edu.cn · +8673185292154
Contactshuoming luo, MD · contact · shuomingluo@@csu.edu.cn
All locations (10)
Quanzhou First People's HospitalRecruiting
Quanzhou, Fujian, China
The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
Nanning, Guangxi, China
Guizhou Provincial People's HospitalRecruiting
Zunyi, Guangzhou, China
Hainan Provincial People's HospitalRecruiting
Haikou, Hainan, China
Changsha Central HospitalRecruiting
Changsha, Hunan, China
Yancheng Third People's HospitalRecruiting
Yancheng, Jiangs, China
The First Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, Jiangxi, China
Yunnan Provincial People's HospitalRecruiting
Kunming, Yunnan, China
The Second Xiangya Hospital of Central South UniversityRecruiting
Changsha, China