Diabetes
Conditions
Keywords
Diabetes, Type 2 diabetes, Diabetes therapy response, Diabetes progression
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.
Interventions
DRUGsecond- or third-line glucose-lowering diabetes treatment
Observation of response and disease progression following clinician's addition of a glucose-lowering diabetes therapy (Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor or Glitazone) to existing therapy.
Sponsors
University of Exeter
King's College London
King's College Hospital NHS Trust
University of Glasgow
NHS Greater Glasgow and Clyde
Newcastle University
Newcastle-upon-Tyne Hospitals NHS Trust
Oxford University Hospitals NHS Trust
Royal Devon and Exeter NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to diabetes therapy | Up to 9 months from commencement of new therapy | The primary outcome will be to compare the clinical characteristics of the patients who show an excellent response or a poor response to specific second- and third-line classes of treatment for Type 2 diabetes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collection of samples for analysis of potential biomarkers | within 9 months of recruitment date | To collect a set of DNA, serum and urine samples to allow analysis of potential genetic and non genetic biomarkers for drug response and diabetes progression. |
Countries
United Kingdom
Outcome results
None listed