Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans (ACRE-CT)

February 11, 2025 updated by: Caristo Diagnostics Limited
To validate the ability of the FatHealth algorithm to identify individuals with pre-diabetes and with type 2 diabetes mellitus

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individuals who had a CCTA as part of their clinical care
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
  • 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.
Experimental: Individuals who had a chest CT as part of their clinical care
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
  • 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.

What is the study measuring?

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
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
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
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
120 minutes after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caristo Diagnostics Limited

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2025

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACRE-CT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans to share participant data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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