Multicenter Study of Fulminant Type 1 Diabetes in China

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ClinicalTrials.gov Identifier: NCT05593081
Recruitment Status : Recruiting
First Posted : October 25, 2022
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
Zhiguang Zhou, Second Xiangya Hospital of Central South University

Study Description
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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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 240 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Multicenter Study of Fulminant Type 1 Diabetes in China
Actual Study Start Date : May 20, 2022
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Groups and Cohorts
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Intervention Details:
  • Genetic: HLA
    Distinguish based on clinical features

Outcome Measures
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Primary Outcome Measures :
  1. Change in serum hemoglobin A1c level [ Time Frame: Every year for up to 5 years ]
    A1c reflects the average blood glucose level


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
blood

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with fulminant 1 diabetes
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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05593081


Contacts
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Contact: zhiguang zhou, MD +8673185292154 zhouzhiguang@csu.edu.cn
Contact: shuoming luo, MD shuomingluo@@csu.edu.cn

Locations
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China, Fujian
Quanzhou First People's Hospital Recruiting
Quanzhou, Fujian, China
Contact: yi zhang, MD         
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China
Contact: xiaoyan chen         
China, Guangxi
The First Affiliated Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China
Contact: zuojie luo         
China, Guangzhou
Guizhou Provincial People's Hospital Recruiting
Zunyi, Guangzhou, China
Contact: jianhua luo         
China, Hainan
Hainan Provincial People's Hospital Recruiting
Haikou, Hainan, China
Contact: huibiao quan         
China, Hunan
Changsha Central Hospital Recruiting
Changsha, Hunan, China, 4100011
Contact: sha liu         
China, Jiangs
Yancheng Third People's Hospital Recruiting
Yancheng, Jiangs, China
Contact: lei yuan         
China, Jiangxi
The First Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China
Contact: zhifen yang         
China, Yunnan
Yunnan Provincial People's Hospital Recruiting
Kunming, Yunnan, China
Contact: heng su         
China
The Second Xiangya Hospital of Central South University Recruiting
Changsha, China, 4100011
Contact: Shuoming Luo, MD         
Contact    13875936536    shuomingluo@csu.edu.cn   
Sponsors and Collaborators
Second Xiangya Hospital of Central South University
More Information
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Responsible Party: Zhiguang Zhou, professor, Second Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT05593081    
Other Study ID Numbers: F1 China
First Posted: October 25, 2022    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhiguang Zhou, Second Xiangya Hospital of Central South University:
type 1 diabetes: HLA ; fulminant
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases