Observational study on fulminant type 1 diabetes in China

Multicenter Study of Fulminant Type 1 Diabetes in China

This study is trying to learn more about fulminant type 1 diabetes by looking at the health data of patients experiencing it for the first time and comparing it to healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Sex: All
• Sponsor: Second Xiangya Hospital of Central South University (Academic / other)
• Locations: 10 sites (Quanzhou, Fujian and 9 other locations)
• Trial ID: NCT05593081 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with fulminant type 1 diabetes who meet specific clinical criteria.

Not a fit: Patients with a prior diagnosis of diabetes or those with chronic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of fulminant type 1 diabetes, potentially enhancing patient outcomes.

How similar studies have performed: While this study explores a specific aspect of type 1 diabetes, similar studies have shown success in identifying genetic factors related to diabetes susceptibility.

Eligibility 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.

Where this trial is running

Quanzhou, Fujian and 9 other locations

• 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)
• Yancheng Third People's Hospital — Yancheng, Jiangs, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Yunnan Provincial People's Hospital — Kunming, Yunnan, China (Recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, China (Recruiting)

Study contacts

• Study coordinator: zhiguang zhou, MD

Conditions Diabetes Mellitus, Type 1; type 1 diabetes: HLA; fulminant