Multicenter Study of Fulminant Type 1 Diabetes in China

NCT ID: NCT05593081

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2027-12-31

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

HLA

Distinguish based on clinical features

Intervention Type: GENETIC

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Zhiguang Zhou

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Quanzhou First People's Hospital

Quanzhou, Fujian, China

Site Status: RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status: RECRUITING

Guizhou Provincial People's Hospital

Zunyi, Guangzhou, China

Site Status: RECRUITING

Hainan Provincial People's Hospital

Haikou, Hainan, China

Site Status: RECRUITING

Changsha Central Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Yancheng Third People's Hospital

Yancheng, Jiangs, China

Site Status: RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

Yunnan Provincial People's Hospital

Kunming, Yunnan, China

Site Status: RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, , China

Site Status: RECRUITING

Countries

China

Central Contacts

zhiguang zhou, MD

Role: CONTACT

zhouzhiguang@csu.edu.cn

+8673185292154

shuoming luo, MD

Role: CONTACT

shuomingluo@@csu.edu.cn

Facility Contacts

yi zhang, MD

Role: primary

xiaoyan chen

Role: primary

zuojie luo

Role: primary

jianhua luo

Role: primary

huibiao quan

Role: primary

sha liu

Role: primary

lei yuan

Role: primary

zhifen yang

Role: primary

heng su

Role: primary

Shuoming Luo, MD

Role: primary

Role: backup

shuomingluo@csu.edu.cn

13875936536

Other Identifiers

F1 China

Identifier Type: -

Identifier Source: org_study_id