Clinical trial NCT02109978: RetroMASTER - Retrospective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes
Official title: Retrospective 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: University of Oxford
name: Oxford University Hospitals NHS Trust
name: University of Dundee
name: NHS Tayside
First posted: 2014-04-10
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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 (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.

Eligibility criteria: Generic 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

Responders Cohort Inclusion Criteria:

* On Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor or Glitazone for \> 4 months.
* Pre-treatment HbA1c≥ 58mmol/mol (7.5%).

Progressors Cohort Inclusion Criteria:

* Type 2 diabetes (not on insulin treatment within 6 months of diagnosis)
* Either: requirement for insulin treatment ≤10 years from diagnosis (defined as insulin treatment or HbA1c ≥ 69mmol/mol (8/5%) treated with two or more non-insulin diabetes therapies) or: no requirement for insulin treatment \>10 years from diagnosis (defined as not on insulin treatment AND HbA1c \<69mmol/mol (8.5%).

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 and rate of diabetes progression
timeFrame: Within 9 months from date of recruitment
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: University of Oxford
state: Oxfordshire
city: Dundee
country: United Kingdom
facility: University of Dundee
Study officials:
affiliation: University of Exeter
name: Andrew T Hattersley, FRCP, DM, BM
role: PRINCIPAL_INVESTIGATOR
References: