Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans

Study Overview
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Brief Summary
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To validate the ability of the FatHealth algorithm to identify individuals with pre-diabetes and with type 2 diabetes mellitus

Detailed Description
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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.

Official Title
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Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans

Conditions
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Pre-diabetes, Diabetes Mellitus

Intervention / Treatment
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* Diagnostic Test: Oral Glucose Tolerance Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-centre, prospective cohort, study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individuals who had a CCTA as part of their clinical care<br>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; | Diagnostic Test: Oral Glucose Tolerance Test<br>* Obtain blood sample for glucose assessment (time 0 sample). This may be obtained via venepuncture or after cannula insertion. Test a small sample using a near patient glucose testing meter. If the result on the glucose meter is greater than or equal to 11mmol/L, send the blood sample urgently to lab. If it is confirmed by biochemistry to be above 11mmol/L, there is no need to continue test. If the result is less than 11mmol/L on meter, give the patient the glucose solution to drink. Collect a further blood sample at 120 minutes. Send samples all together to laboratory for glucose measurement.<br>|
| Experimental: Individuals who had a chest CT as part of their clinical care<br>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. | Diagnostic Test: Oral Glucose Tolerance Test<br>* Obtain blood sample for glucose assessment (time 0 sample). This may be obtained via venepuncture or after cannula insertion. Test a small sample using a near patient glucose testing meter. If the result on the glucose meter is greater than or equal to 11mmol/L, send the blood sample urgently to lab. If it is confirmed by biochemistry to be above 11mmol/L, there is no need to continue test. If the result is less than 11mmol/L on meter, give the patient the glucose solution to drink. Collect a further blood sample at 120 minutes. Send samples all together to laboratory for glucose measurement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants identified with pre-diabetes/type 2 diabetes mellitus when fasting blood sample test results are compared against FatHealth algorithm results | 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 | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants identified with pre-diabetes/type 2 diabetes mellitus when oral glucose tolerance test results are compared against FatHealth algorithm results | 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 | 120 minutes after baseline |