Pre-diabetesACRE-CTNCT05058690
Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans
A study testing Oral Glucose Tolerance Test in people with Pre-diabetes and Diabetes Mellitus, run by Caristo Diagnostics Limited.
Trial summary
To validate the ability of the FatHealth algorithm to identify individuals with pre-diabetes and with type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes, Diabetes Mellitus
- What is being tested?
- Oral Glucose Tolerance Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To validate the ability of the FatHealth algorithm to identify individuals with pre-diabetes and with type 2 diabetes mellitus
Read the 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:
- 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.
- Conditions
- Pre-diabetes, Diabetes Mellitus
- Being tested
- Oral Glucose Tolerance Test
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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. Receives: Diagnostic Test: Oral Glucose Tolerance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 120 minutes after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start15 Feb 2025 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre, prospective cohort, study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caristo Diagnostics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oxford, University of Leeds, Milton Keynes University Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058690
- Sponsor's protocol ID
- ACRE-CT
- Acronym
- ACRE-CT
- Status last verified
- Feb 2025
- First submitted
- 8 Sep 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans
- ClinicalTrials.gov ID
- NCT05058690
- Acronym / sponsor ID
- ACRE-CT / ACRE-CT
- Conditions
- Pre-diabetes, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Caristo Diagnostics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University of Oxford, University of Leeds, Milton Keynes University Hospital NHS Foundation Trust
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multi-centre, prospective cohort, study
| Arm | Type | Receives |
|---|---|---|
| Individuals who had a CCTA as part of their clinical care | Experimental | Diagnostic Test: Oral Glucose Tolerance TestApproximately 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; |
| Individuals who had a chest CT as part of their clinical care | Experimental | Diagnostic Test: Oral Glucose Tolerance TestApproximately 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 may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Individuals who had a CCTA as part of their clinical care, Individuals who had a chest CT as part of their clinical care |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No. No plans to share participant data with other researchers
Related trials for Pre-diabetes
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
RecruitingPhase 2
PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC
Lung Adenocarcinoma
RecruitingObservational study
Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients
Diabetic Retinopathy, Diabetes Mellitus, Type 2
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Glucose Tolerance Test in people with Pre-diabetes and Diabetes Mellitus, run by Caristo Diagnostics Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Dicken, PhD (+44 (0) 1865 950720, lisa.dicken@caristo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.