Multicenter Study of Fulminant Type 1 Diabetes in China

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Multicenter Study of Fulminant Type 1 Diabetes in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05593081
• Other study ID #: F1 China
• Status: Recruiting
• Start date: May 20, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2022
• Source: Second Xiangya Hospital of Central South University
• Contact: zhiguang zhou, MD
• Phone: +8673185292154
• Email: zhouzhiguang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Genetic:
• HLA
Distinguish based on clinical features

Locations

Country	Name	City	State
China	Changsha Central Hospital	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Hainan Provincial People's Hospital	Haikou	Hainan
China	Yunnan Provincial People's Hospital	Kunming	Yunnan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Quanzhou First People's Hospital	Quanzhou	Fujian
China	Yancheng Third People's Hospital	Yancheng	Jiangs
China	Guizhou Provincial People's Hospital	Zunyi	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum hemoglobin A1c level	A1c reflects the average blood glucose level	Every year for up to 5 years
Secondary	Change in titer of autoantibodies	Glutamic acid decarboxylase antibody	Every year for up to 5 years
Secondary	Treatment options	Insulin use protocol and total amount	Every year for up to 5 years
Secondary	The incidence of chronic complications of diabetes mellitus	The incidence of diabetic neuropathy, diabetic nephropathy and diabetic retinopathy	up to 5 years