Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral Glucose Tolerance Test.
- Who it may be relevant to
- Registry conditions: Pre-diabetes, Diabetes Mellitus. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Oral Glucose Tolerance Test
* 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. * Co
Primary outcome measures
- Number of participants identified with pre-diabetes/type 2 diabetes mellitus when fasting blood sample test results are compared against FatHealth algorithm results [Time frame: Baseline]
Secondary outcome measures (1)
- Number of participants identified with pre-diabetes/type 2 diabetes mellitus when oral glucose tolerance test results are compared against FatHealth algorithm results [Time frame: 120 minutes after baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05058690 · ACRE-CT