Observational study on fulminant type 1 diabetes in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on fulminant type 1 diabetes (FT1D) by collecting clinical data from patients experiencing their first episode of the disease. It aims to analyze the clinical characteristics and identify HLA susceptibility genes associated with FT1D by comparing data from FT1D patients to age-sex-matched healthy controls. The research includes a comprehensive analysis of various laboratory indicators and genetic factors to enhance understanding and improve diagnosis and treatment of FT1D. A total of 240 FT1D patients and 250 healthy controls will be involved in the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Quanzhou First People's Hospital
  Quanzhou, Fujian, China Recruiting
• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• Guizhou Provincial People's Hospital
  Zunyi, Guangzhou, China Recruiting
• Hainan Provincial People's Hospital
  Haikou, Hainan, China Recruiting
• Changsha Central Hospital
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: zhiguang zhou, MD
• Email: zhouzhiguang@csu.edu.cn
• Phone: +8673185292154

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.