Diabetes Research on Patient Stratification (DIRECT)
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|ClinicalTrials.gov Identifier: NCT03814915|
Recruitment Status : Completed
First Posted : January 24, 2019
Last Update Posted : January 18, 2020
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||3049 participants|
|Official Title:||DIabetes REsearCh on Patient straTification|
|Actual Study Start Date :||October 15, 2012|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||July 31, 2019|
Study 1 - Prediabetes
The primary objective of Study 1 is to collect biosamples and information that might yield novel, predictive biomarkers for glycaemic deterioration in non-diabetic high-risk participants.
Participants in Study 1 were recruited from existing prospective cohort studies in or around each of the following European cities: Malmö, Sweden (Malmö Diet and Cancer Study); Amsterdam, The Netherlands (Hoorn Study); Copenhagen, Denmark (Inter99); and Kuopio, Finland (METSIM). A clinically practicable screening tool (DIRECT-DETECT) was used to identify at-risk participants from existing cohort studies, who were then recruited into this new prospective cohort study (Study 1).
Study 2- Diabetic
The primary objective of Study 2 is to collect biosamples and information that might yield novel, predictive biomarkers for glycaemic deterioration in people who have recently been diagnosed with type 2 diabetes. Participants in Study 2 of DIRECT are recruited from or nearby each of the following European cities: Malmö, Sweden; Amsterdam, the Netherlands; Copenhagen, Denmark; Exeter, UK; Newcastle, UK; Dundee, UK. Potential participants are recruited through targeted searches of existing databases and research registers combined with person-to-person contact at educational clinics and through routine retinal screening programmes.
- Glycemic deterioration [ Time Frame: Up to 10 years follow-up ]Change in glucose (or HbA1c) over time and/or progression to anti diabetic medications/insulin
Biospecimen Retention: Samples With DNA
Blood Omics: Fasting blood samples taken for genomic, transcriptomic, proteomic and metabolomic assessments.
Microbiome Urine Toenail clippings
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814915
|Principal Investigator:||Ewan Pearson, FRCP||University of Dundee|
|Principal Investigator:||Paul W Franks, PhD||Lund University|