跳至主要内容
临床试验/NCT04805970
NCT04805970进行中(未招募)不适用

REsearching Covid-19 Outcomes in Diabetes (RECODE)

AdventHealth Translational Research Institute1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
35
试验地点
1
主要终点
Measure and characterize organ volume change in patients with and without diabetes through use of summary statistics.

研究概览

简要总结

The purpose of this study is to observe any changes that may occur to certain organs following a confirmed diagnosis of COVID-19 in people with and without diabetes.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • For Type 2 Diabetes (T2D)
  • Male or female 18 years of age and older willing and able to give informed consent to participate in the study
  • Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months).
  • Diagnosis of T2D according to American Diabetes Association (ADA) criteria.
  • Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.
  • For participant without Type 2 Diabetes (T2D)
  • Male or female 18 years of age and older willing and able to give informed consent to participate in the study
  • Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months).
  • Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.

排除标准

  • Symptoms of active respiratory viral infection:
  • high temperature (over 37.8°C/100.4°F)
  • cough (consistent for over an hour; 3 or more episodes in 24 hours)
  • Any history of Type I diabetes
  • The participant may not enter the study with any known contraindication to magnetic resonance imaging including
  • Pregnancy, lactation or 6 months postpartum from the scheduled date of collection
  • Metal implants (pacemaker, aneurysm clips) based on Investigator's judgment at Screening
  • Unable to participate in MRI assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on Investigator's judgment at Screening
  • Unable to tolerate MRI imaging or claustrophobia
  • Any condition, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.

结局指标

主要结局

Measure and characterize organ volume change in patients with and without diabetes through use of summary statistics.

时间窗: 1 year

Patients recovering from the COVID-19 disease

次要结局

未报告次要终点

研究者

发起方
AdventHealth Translational Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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