Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans

NCT05058690 | Not Yet Recruiting

• 1 other identifier: ACRE-CT
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pre-diabetes; Diabetes Mellitus

Outcome Measures

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

  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 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

  120 minutes after baseline

Study Arms (2)

Individuals who had a CCTA as part of their clinical care

EXPERIMENTAL

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

Individuals who had a chest CT as part of their clinical care

EXPERIMENTAL

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

Interventions

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.

Individuals who had a CCTA as part of their clinical care; Individuals who had a chest CT as part of their clinical care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Caristo Diagnostics Limited: lead
• University of Oxford: collaborator
• University of Leeds: collaborator
• Milton Keynes University Hospital NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Central Study Contacts

Lisa Dicken, PhD

CONTACT

+44 (0) 1865 950720; lisa.dicken@caristo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Personal identifiable data (including the code-break/participant key) collected at the recruitment site will be recorded electronically on a database that is stored on an access-restricted computer and either encrypted and/or located on a secure server and accessed only by authorised staff. Any copies leaving the study site will be completely anonymised/de-identified. Informed consent forms that contain participant names will be stored securely at study sites in locked cupboards and will only be accessible to study staff and authorised personnel.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-centre, prospective cohort, study

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 28, 2021
• Study Start: February 15, 2025
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share