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Clinical Trials in China / NCT05593081
Recruiting Observational

Multicenter Study of Fulminant Type 1 Diabetes in China

NCT05593081 · tracked via the Priya Life Science China tracker
Sponsor
Second Xiangya Hospital of Central South University
Phase
Observational
Started
2022-05-20
Last updated
2022-10-25

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

HLA

HLA: Distinguish based on clinical features

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Quanzhou First People's Hospital Quanzhou Fujian Recruiting
The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi Recruiting
Guizhou Provincial People's Hospital Zunyi Guangzhou Recruiting
Hainan Provincial People's Hospital Haikou Hainan Recruiting
Changsha Central Hospital Changsha Hunan Recruiting
Yancheng Third People's Hospital Yancheng Jiangs Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
Yunnan Provincial People's Hospital Kunming Yunnan Recruiting
The Second Xiangya Hospital of Central South University Changsha China Recruiting

More Second Xiangya Hospital of Central South University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05593081 on ClinicalTrials.gov ↗ ← All trials in China