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| Name | Class |
|---|---|
| University of Oxford | OTHER |
| University of Leeds | OTHER |
| Milton Keynes University Hospital NHS Foundation Trust | OTHER_GOV |
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To validate the ability of the FatHealth algorithm to identify individuals with pre-diabetes and with type 2 diabetes mellitus
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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; |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Glucose Tolerance Test | Diagnostic Test |
|
| 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 | 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 |
| 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 | 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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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Dicken, PhD | Contact | +44 (0) 1865 950720 | lisa.dicken@caristo.com |
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No plans to share participant data with other researchers
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Multi-centre, prospective cohort, study
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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.
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| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |