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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Genetic: HLA

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.

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: zhiguang zhou, MD; Phone Number: +8673185292154; Email: zhouzhiguang@csu.edu.cn
• Study Contact Backup: Name: shuoming luo, MD; Email: shuomingluo@@csu.edu.cn

Study Locations

• China
  • Changsha, China, 4100011
    • Recruiting
    • The Second Xiangya Hospital Of Central South University
    • Contact: Shuoming Luo, MD
    • Contact: Phone Number: 13875936536; Email: shuomingluo@csu.edu.cn
  • Fujian
    • Quanzhou, Fujian, China
      • Recruiting
      • Quanzhou First People's Hospital
      • Contact: yi zhang, MD
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: xiaoyan chen
  • Guangxi
    • Nanning, Guangxi, China
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: zuojie luo
  • Guangzhou
    • Zunyi, Guangzhou, China
      • Recruiting
      • Guizhou Provincial People's Hospital
      • Contact: jianhua luo
  • Hainan
    • Haikou, Hainan, China
      • Recruiting
      • Hainan Provincial People's Hospital
  • Hunan
    • Changsha, Hunan, China, 4100011
      • Recruiting
      • Changsha Central Hospital
      • Contact: sha liu
  • Jiangs
    • Yancheng, Jiangs, China
      • Recruiting
      • Yancheng Third People's Hospital
      • Contact: lei yuan
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital Of Nanchang University
      • Contact: zhifen yang
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • Yunnan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with fulminant 1 diabetes

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum hemoglobin A1c level	A1c reflects the average blood glucose level	Every year for up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in titer of autoantibodies	Glutamic acid decarboxylase antibody	Every year for up to 5 years
Treatment options	Insulin use protocol and total amount	Every year for up to 5 years
The incidence of chronic complications of diabetes mellitus	The incidence of diabetic neuropathy, diabetic nephropathy and diabetic retinopathy	up to 5 years

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Anticipated): December 31, 2027
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 22, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 22, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: type 1 diabetes: HLA ; fulminant
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: F1 China

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No