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Multicenter Study of Fulminant Type 1 Diabetes in China

Multicenter Study of Fulminant Type 1 Diabetes in China

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05593081
Enrollment
240
Registered
2022-10-25
Start date
2022-05-20
Completion date
2027-12-31
Last updated
2022-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

type 1 diabetes: HLA ; fulminant

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.

Interventions

GENETICHLA

Distinguish based on clinical features

Sponsors

Second Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in serum hemoglobin A1c levelEvery year for up to 5 yearsA1c reflects the average blood glucose level

Secondary

MeasureTime frameDescription
Change in titer of autoantibodiesEvery year for up to 5 yearsGlutamic acid decarboxylase antibody
Treatment optionsEvery year for up to 5 yearsInsulin use protocol and total amount
The incidence of chronic complications of diabetes mellitusup to 5 yearsThe incidence of diabetic neuropathy, diabetic nephropathy and diabetic retinopathy

Countries

China

Contacts

Primary Contactzhiguang zhou, MD
zhouzhiguang@csu.edu.cn+8673185292154
Backup Contactshuoming luo, MD
shuomingluo@@csu.edu.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026