NCT05593081 Multicenter Study of Fulminant Type 1 Diabetes in China
| NCT ID | NCT05593081 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Xiangya Hospital of Central South University |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2022-05-20 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2022-05-20 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05593081 clinical trial?
This trial is open to participants of all sexes, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05593081 currently recruiting?
Yes, NCT05593081 is actively recruiting participants. Contact the research team at zhouzhiguang@csu.edu.cn for enrollment information.
Where is the NCT05593081 trial being conducted?
This trial is being conducted at Quanzhou, China, Guangzhou, China, Nanning, China, Zunyi, China and 6 additional locations.
Who is sponsoring the NCT05593081 clinical trial?
NCT05593081 is sponsored by Second Xiangya Hospital of Central South University. The trial plans to enroll 240 participants.
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