NCT02109978

RetroMASTER - Retrospective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes

Retrospective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes:

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 562 (actual)
• Sponsor: Royal Devon and Exeter NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study will examine extreme responders to second- and third-line Type 2 Diabetes (T2D) therapy using a retrospective approach and patients with slow or fast diabetes progression.

Detailed description

PILOT Phase (March 2013 - Dec 2014) Patients will be recruited initially from 2 centres, plus Exeter as a pre-PILOT centre. Patients with particularly good or poor response to second- and third-line Type 2 diabetes treatments and patients progressing to insulin either particularly quickly or particularly slowly will be recruited from primary, secondary, or community settings. Fasting blood and urine samples will be collected, along with standard biomeasures and information will be collected about medical history and prescribing history. All study documentation and sample materials will be sent out to sites from the coordinating centre. Sites will be expected to process and freeze samples and send them to the Central Laboratory managed by the Chief Inspector's site where they will be analysed for genetic factors, glycaemic markers and other markers related to drug response. POST-PILOT Phase (Jan 2015- Oct 2017): Subject to feasibility, interim analysis and continuation of funding from Medical Research Council (MRC), this project will continue for another three years.

Conditions

• Diabetes

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-04-10
• Last updated: 2018-06-21

Locations

3 sites across 1 country: United Kingdom