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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05058690
Other study ID # ACRE-CT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date August 31, 2024

Study information

Verified date February 2024
Source Caristo Diagnostics Limited
Contact Lisa Dicken, PhD
Phone +44 (0) 1865 950720
Email lisa.dicken@caristo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 180
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Caristo Diagnostics Limited Milton Keynes University Hospital NHS Foundation Trust, University of Leeds, University of Oxford

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of participants identified with pre-diabetes/type 2 diabetes mellitus when oral glucose tolerance test results are compared against FatHealth algorithm results 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
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