Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans
- Conditions
- Pre-diabetesDiabetes Mellitus
- Interventions
- Diagnostic Test: Oral Glucose Tolerance Test
- Registration Number
- NCT05058690
- Lead Sponsor
- Caristo Diagnostics Limited
- Brief Summary
To validate the ability of the FatHealth algorithm to identify individuals with pre-diabetes and with type 2 diabetes mellitus
- Detailed Description
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:
1. 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
2. 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 180
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individuals who had a chest CT as part of their clinical care Oral Glucose Tolerance Test 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. Individuals who had a CCTA as part of their clinical care Oral Glucose Tolerance Test 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;
- Primary Outcome Measures
Name Time Method Number of participants identified with pre-diabetes/type 2 diabetes mellitus when fasting blood sample test results are compared against FatHealth algorithm results 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
- Secondary Outcome Measures
Name Time Method 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 The investigators will measure if the oral glucose tolerance test 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