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NCT Number: NCT05058690

Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral glucose tolerance test

Diagnostic 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.
  • Collect a further blood sample at 120 minutes.
  • Send samples all together to laboratory for glucose measurement.

Primary outcomes

  1. 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

    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 outcomes

  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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Dicken, PhD

CONTACT

[email protected]

+44 (0) 1865 950720

Sponsors and collaborators

Lead sponsor

Caristo Diagnostics Limited

Industry

Collaborators

  • Milton Keynes University Hospital NHS Foundation Trust
  • University of Leeds
  • University of Oxford

Registry information

Acronym: ACRE-CT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2021
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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