Clinical trial NCT02105792: PROMASTER - PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes
Official title: PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Diabetes
Type 2 diabetes
Diabetes therapy response
Diabetes progression
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Exeter
name: King's College London
name: King's College Hospital NHS Trust
name: University of Glasgow
name: NHS Greater Glasgow and Clyde
name: Newcastle University
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Oxford University Hospitals NHS Trust
First posted: 2014-04-07
Enrollment: 820
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified in primary care and secondary care. The method for patient identification may differ between sites and could involve:

GP Searches; Secondary Care Clinician Referral; Research Database Searches.

Brief summary: This study will examine extreme responders to second- and third-line Type 2 diabetes therapy using a prospective approach, and patients with slow or fast diabetes progression using a retrospective approach.

Detailed description: PILOT Phase (March 2013 - Dec 2014) Participants will be recruited initially from 4 centres. Patients due to start second- and third-line Type 2 diabetes treatments, and patients progressing to insulin either particularly quickly or particularly slowly, will be recruited from primary care, secondary care, or community settings. Fasting blood and urine samples will be collected, together with standard biomeasures and information about medical history and prescribing history. Participants in Responders Arm will be contacted by telephone approximately 3 months after starting their new second/third-line agent to review their current medication and blood glucose level. If a 3 month HbA1c has not been collected as part of routine clinical care, the research team will arrange this. Participants will be asked to return for a blood and urine test approximately 6 months after their new treatment was started. This visit will be brought forward should the participant advise they are about to further change their treatment, to enable their samples to be collected in advance of their proposed treatment change.

All study documentation and sample materials will be distributed to sites from the Coordinating Centre. Sites will be expected to process and freeze samples and send them to the Chief Investigator's Central Laboratory 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 study will continue for another 3 years.

Eligibility criteria: Inclusion Criteria:

* Demographics: Age 18-90 inclusive
* Ethnicity: Reflective of local demographic
* Medical History: Clinical diagnosis of Type 2 diabetes
* Mental Capacity: Capacity to Consent

Exclusion Criteria:

* Age less than 18 years old and greater than 90 years old
* Incapacity to consent
* Type 1 diabetes.

Primary outcomes:
measure: Response to diabetes therapy
timeFrame: Up to 9 months from commencement of new therapy
Secondary outcomes:
measure: Collection of samples for analysis of potential biomarkers
timeFrame: within 9 months of recruitment date
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
state: Oxfordshire
city: Newcastle upon Tyne
country: United Kingdom
facility: University of Newcastle
state: Tyne And Wear
city: Glasgow
country: United Kingdom
facility: University of Glasgow
city: London
country: United Kingdom
facility: King's College University of London
Study officials:
affiliation: University of Exeter
name: Andrew T Hattersley, FRCP, DM, BM
role: PRINCIPAL_INVESTIGATOR
References: