Multicenter Study of Fulminant Type 1 Diabetes in China

Last updated: October 22, 2022
Sponsor: Second Xiangya Hospital of Central South University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 1

Treatment

N/A

Clinical Study ID

NCT05593081
F1 China
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

patients with fulminant 1 diabetes Inclusion Criteria:

  1. diabetic ketosis or ketoacidosis occurred soon after the onset of hyperglycemicsymptoms; 2) patient presented with plasma glucose ≥16.0 mmol/L and HbA1c <8.7% at thefirst visit; and 3) patient had urinary C-peptide excretion <10 µg/day,fasting serumC-peptide level <0.10 nmol/L, or postprandial serum C-peptide <0.17 nmol/L at onset

Exclusion

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 andextracted 3ml of peripheral blood for DNA extraction. Exclusion Criteria:
  • The exclusion criteria were as follows: (1) with heart, brain, liver, kidney or otherchronic diseases; (2) with other types of autoimmune diseases; (3) with malignanttumors; (4) with a family history of diabetes.

Study Design

Total Participants: 240
Study Start date:
May 20, 2022
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Quanzhou First People's Hospital

    Quanzhou, Fujian
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi
    China

    Active - Recruiting

  • Guizhou Provincial People's Hospital

    Zunyi, Guangzhou
    China

    Active - Recruiting

  • Hainan Provincial People's Hospital

    Haikou, Hainan
    China

    Active - Recruiting

  • Changsha Central Hospital

    Changsha, Hunan 4100011
    China

    Active - Recruiting

  • Yancheng Third People's Hospital

    Yancheng, Jiangs
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • Yunnan Provincial People's Hospital

    Kunming, Yunnan
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, 4100011
    China

    Active - Recruiting

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