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Идёт набор NCT05593081

Multicenter Study of Fulminant Type 1 Diabetes in China

— Наблюдательное Diabetes Mellitus, Type 1

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: HLA.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Type 1. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Генная терапия HLA
    Distinguish based on clinical features

Первичные конечные точки

  • Change in serum hemoglobin A1c level [Срок оценки: Every year for up to 5 years]
Вторичные конечные точки (3)
  • Change in titer of autoantibodies [Срок оценки: Every year for up to 5 years]
  • Treatment options [Срок оценки: Every year for up to 5 years]
  • The incidence of chronic complications of diabetes mellitus [Срок оценки: up to 5 years]

Критерии участия

patients with fulminant 1 diabetes

Критерии включения

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

Критерии исключения

Case reports of previously diagnosed with diabetes were excluded.

Healthy Volunteers

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Китай · 10 центров
  • Quanzhou First People's Hospital — Quanzhou
  • The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
  • The First Affiliated Hospital of Guangxi Medical University — Nanning
  • Guizhou Provincial People's Hospital — Zunyi
  • Hainan Provincial People's Hospital — Haikou
  • Changsha Central Hospital — Чанша
  • Yancheng Third People's Hospital — Yancheng
  • The First Affiliated Hospital of Nanchang University — Nanchang
  • … и ещё 2 центра

Идентификаторы

NCT: NCT05593081 · F1 China

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗