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Clinical Trial Summary

Prospective, observational cohort study to cross-sectionally assess the health of multiple organs, using multiparametric abdominal magnetic resonance imaging (MRI) scan, and understand if resulting MRI metrics can predict future clinical events over a period of 10 years, in patients diagnosed with type 2 diabetes and concurrent diabetic retinopathy (as per their standard of care).


Clinical Trial Description

This will be a multi-site study adopting a prospective, observational cohort study design. There will be no intervention to the standard of care. Study participants will be enrolled in this study for a total of 10 years, with only 1 month of active participation. Participants will be required to attend a screening visit and 2 study visits. The screening visit will involve a medical review and receiving informed consent based on the participant information leaflet already communicated to the patient, pre-screening. The first study visit- baseline (visit 1) - will involve anthropometric measurements and taking a blood and urine sample in order to perform standard of care measurements for type 2 diabetes at baseline and relevant circulating biomarkers. The second study visit will involve having a multiparametric MRI scan. Both visits will be within 21 days of the screening visit and carried out at local study sites. Clinical outcome measurements, blood samples and urine samples will be collected to assess the natural history of diabetes disease progression. Optional blood sample will be collected for future genetic testing. Participants will be asked to give consent for access to their medical records held at their local hospital and NHS Digital to obtain information on Hospital admissions (Hospital Episode Statistics), and mortality data collected by the Office for National Statistics (ONS), also provided by NHS Digital. This data will be collected at 1, 3 and 10 years after baseline assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05057403
Study type Observational
Source Perspectum
Contact Kim Chapman
Phone 01865 655343
Email [email protected]
Status Not yet recruiting
Phase
Start date November 2021
Completion date October 2033

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