Long-Term Sequelae of SARS-COV-2 Infection: Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Measure of glycosylated glucose percentage (HbA1c)
研究概览
简要总结
Hospitalized patients with severe COVID-19 have an increased incidence of insulin resistance, impaired beta cell function, glucose intolerance (prediabetes), and overt type 2 diabetes (T2D) compared to non-hospitalized patients with COVID-19 and COVID-19 negative individuals on long-term follow up.
详细描述
The purpose of this research study is to understand the long-term effects of COVID-19 infection on individuals without any prior history of diabetes. This study will look at several measures of diabetes, such as glycemic control (blood glucose/sugar levels), function of beta cells (cells that make insulin to control sugar), insulin secretion and insulin sensitivity (fasting insulin levels).
The following participants will be enrolled: 1) have had COVID-19 infection and were hospitalized and recovered, or 2) have had mild COVID-19 infection and were seen at outpatient clinics or ER and were not required to be hospitalized, or 3) have not had COVID-19 infection but were seen in outpatient clinics or ER during the same time period.
The researchers hope to learn the long-term effects of COVID-19 infection in hospitalized patients. Specifically, they will be focusing on the subsequent development of diabetes and associated metabolic disturbances, such as impaired insulin secretion and insulin resistance. A relationship between COVID-19 and diabetes needs to be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass index (BMI) < 40 kg/m2
排除标准
- •History of diabetes prior to SARS-CoV-2 infection
- •Took medications used to treat diabetes prior to SARS-CoV-2 infection
- •History of myocardial infarction or stroke within 6 months
- •History of major organ system disease prior to COVID-19 infection
研究组 & 干预措施
Severe COVID-19 Group
Hospitalized in ICU with COVID-19 (PCR positive) and recovered
干预措施: Measure of physiologic parameters (Other)
Mild COVID-19 positive Group
COVID-19 positive (by PCR) who recovered from mild COVID-19 and were seen in outpatient clinics or ER with symptoms that did not justify hospitalization.
干预措施: Measure of physiologic parameters (Other)
COVID-19 negative Group
COVID-19 negative (by PCR) and seen in outpatient clinics or ER during same time period as Groups I and II.
干预措施: Measure of physiologic parameters (Other)
结局指标
主要结局
Measure of glycosylated glucose percentage (HbA1c)
时间窗: Baseline to 24 months
Change in HbA1c, and indication of glucose levels over a 3 month period
Measure of free plasma glucose (FPG)
时间窗: Baseline to 24 months
Change in FPG
次要结局
- Body Weight(Baseline to 24 months)