Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Number of participants identified with pre-diabetes/type 2 diabetes mellitus when fasting blood sample test results are compared against FatHealth algorithm results
研究概览
简要总结
To validate the ability of the FatHealth algorithm to identify individuals with pre-diabetes and with type 2 diabetes mellitus
详细描述
This multicentre prospective study will evaluate the ability of the FatHealth technology to correctly identify individuals with pre-diabetes and diabetes, validating the technology against the current gold-standard diagnostic method, oral glucose tolerance testing.
Participants will be individuals who have undergone a CT scan of the chest (coronary CT angiogram [CCTA] or CT chest) as part of observational cohort studies.
Participants will be invited for an oral glucose tolerance test (OGTT), which is the current gold-standard method for detecting pre-diabetes and diabetes mellitus. All patients must have an evaluable OGTT. The study population will include:
- Approximately 90 individuals who had a CCTA as part of their clinical care (45 identified as having an abnormal FatHealth algorithm calculation and 45 with a normal FatHealth algorithm calculation) will undergo OGTT which is evaluable; and
- Approximately 90 individuals who had a chest CT as part of their clinical care (45 identified as having an abnormal FatHealth algorithm calculation and 45 with a normal FatHealth algorithm calculation) will undergo OGTT which is evaluable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Personal identifiable data (including the code-break/participant key) collected at the recruitment site will be recorded electronically on a database that is stored on an access-restricted computer and either encrypted and/or located on a secure server and accessed only by authorised staff. Any copies leaving the study site will be completely anonymised/de-identified. Informed consent forms that contain participant names will be stored securely at study sites in locked cupboards and will only be accessible to study staff and authorised personnel.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 to 80 years.
- •Body mass index (BMI) ≥ 25kg/m2
- •FatHealth status assessed as the following:
- •Elevated FatHealth status (50% of participants)
- •Non-elevated FatHealth status (50% of participants)
排除标准
- •Participant is unable or unwilling to give informed consent
- •Participant is unable to understand English language
- •Confirmed diagnosis of diabetes mellitus treated with oral medication or Insulin
结局指标
主要结局
Number of participants identified with pre-diabetes/type 2 diabetes mellitus when fasting blood sample test results are compared against FatHealth algorithm results
时间窗: Baseline
The investigators will measure if the fasting blood sample results indicate that the individual has pre-diabetes/type 2 diabetes mellitus and compare if our FatHealth algorithm indicates the same results for the individual
次要结局
- Number of participants identified with pre-diabetes/type 2 diabetes mellitus when oral glucose tolerance test results are compared against FatHealth algorithm results(120 minutes after baseline)