Clinical trial NCT05593081: Multicenter Study of Fulminant Type 1 Diabetes in China
Official title: Multicenter Study of Fulminant Type 1 Diabetes in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 1
Keywords: type 1 diabetes: HLA ; fulminant
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with fulminant 1 diabetes

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.

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.

Primary outcomes:
measure: Change in serum hemoglobin A1c level
timeFrame: Every year for up to 5 years
Secondary outcomes:
measure: Change in titer of autoantibodies
timeFrame: Every year for up to 5 years
measure: Treatment options
timeFrame: Every year for up to 5 years
measure: The incidence of chronic complications of diabetes mellitus
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Quanzhou
country: China
facility: Quanzhou First People's Hospital
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Zunyi
country: China
facility: Guizhou Provincial People's Hospital
state: Guangzhou
city: Haikou
country: China
facility: Hainan Provincial People's Hospital
state: Hainan
city: Changsha
country: China
facility: Changsha Central Hospital
state: Hunan
city: Yancheng
country: China
facility: Yancheng Third People's Hospital
state: Jiangs
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Kunming
country: China
facility: Yunnan Provincial People's Hospital
state: Yunnan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
Study officials:
References: