Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans

NCT ID: NCT05058690

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2025-02-28

Brief Summary

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.

Conditions

Pre-diabetes; Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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;

Group Type: EXPERIMENTAL

Oral Glucose Tolerance Test

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Oral Glucose Tolerance Test

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

University of Leeds

OTHER

Sponsor Role: collaborator

Milton Keynes University Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

Caristo Diagnostics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lisa Dicken, PhD

Role: CONTACT

lisa.dicken@caristo.com

+44 (0) 1865 950720

Other Identifiers

ACRE-CT

Identifier Type: -

Identifier Source: org_study_id