Covid-19 and Type 1 Diabetes - a Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Stimulated insulin secretion
研究概览
简要总结
Although recognized as an autoimmune disease the etiology of type 1 diabetes remains unknown. Virus infections has been suggested as a possible agent triggering the autoimmune reaction finally resulting in beta-cell destruction and fate of insulin secretion. SARS Cov-2 virus enters the infected cells by binding to the ACE-2 receptor, which is abundant in many tissues including the pancreas. Accordingly, SARS Covid-19 infection may trigger the development of type 1 diabetes either by an activation of the immune system or directly via beta-cell infection and destruction.
Our aim is to study the impact of the Covid-19 epidemic on the development of type 1 diabetes. This will be done in two ways: a clinical study and an epidemiological follow up. During the next two years, adult patients with newly diagnosed type 1 diabetes will be asked to participate. Type 1 diabetes will be diagnosed by usual means and a mixed meal tolerance test will be performed at time of diagnosis and after one year to evaluate beta-cell function. People with type 1 diabetes and serologically documented previous SARS Covid-19 will be compared with people with no previous infection regarding beta-cell function and fate of insulin secretion. In addition, we will estimate the number of new diagnosed type 1 diabetes patients compared to previous years.
详细描述
Background
Although recognized as an autoimmune disease, the etiology of type 1 diabetes mellitus (T1D) remains undetermined. One dominant hypothesis is that a recent virus infection elicits or enhances an autoimmune reaction, resulting in CD4+ and CD8+ T-cells recognizing pancreatic antigens and subsequently targeting the beta-cells of the pancreas. This results in a gradual but irreversible loss of beta-cell function.
Various enterovirus species have been suspected as causative factors of T1D. However, many different viruses may carry the potential to induce T1D via one of the above-mentioned mechanisms, including respiratory infections.
Most people are presently immunologically inert to SARS-Cov-2, but a large proportion of the world's population is expected to be infected over the next few years, with the global focus having now shifted to slowing the spread (1). The pandemic of COVID-19 therefore provides an opportunity to study a possible correlation between a novel type of virus infection and the development of T1D.
Aim
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1D patients diagnosed according to standard practice (including Hba1c, C-peptide, presence of GAD (or islet-cell) antibodies).
- •Patient is attending a hospital unit in Denmark or Portugal, due to T1D.
- •Age 18 years or above.
排除标准
- •Severe psychiatric disorder or other conditions deemed to impair the patient's informed consent and participation in the study.
结局指标
主要结局
Stimulated insulin secretion
时间窗: One years
C-peptide AUC of the MMTT at baseline and one year follow-up
次要结局
- Fasting blood glucose(One years)
- HbA1c(One years)
研究者
Claus Bogh Juhl
MD., Ph.D., Clinical Professor
Esbjerg Hospital - University Hospital of Southern Denmark