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NCT Number: NCT05593081

Multicenter Study of Fulminant Type 1 Diabetes in China

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Quanzhou First People's Hospital, Quanzhou, Fujian, China

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About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

patients with fulminant 1 diabetes

Inclusion criteria

  • 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.

Treatment and study plan

HLA

Genetic

Distinguish based on clinical features

Primary outcomes

  1. Change in serum hemoglobin A1c level

    Time frame: Every year for up to 5 years

    A1c reflects the average blood glucose level

Secondary outcomes

  1. Change in titer of autoantibodies

    Time frame: Every year for up to 5 years

    Glutamic acid decarboxylase antibody

  2. Treatment options

    Time frame: Every year for up to 5 years

    Insulin use protocol and total amount

  3. The incidence of chronic complications of diabetes mellitus

    Time frame: up to 5 years

    The incidence of diabetic neuropathy, diabetic nephropathy and diabetic retinopathy

Study contacts

Contact information is provided by the study sponsor or research team.

shuoming luo, MD

CONTACT

shuomingluo@@csu.edu.cn

zhiguang zhou, MD

CONTACT

[email protected]

+8673185292154

Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 25, 2022
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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