RetroMASTER
Retrospective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes:
Sponsor study identifier
Secondary identifiers
OTHER · Research Ethics Committee
observational
562
1 country
3
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 8, 2014
Actual (reported)April 10, 2014
Actual (reported)May 2015
Actual (reported)May 2015
Actual (reported)Response to diabetes therapy and rate of diabetes progression
The primary outcome will be to compare the clinical characteristics of the patients who show an excellent response or poor response to specific second- and third- line classes of treatment for Type 2 diabetes; and of those patients that show rapid progression of Type 2 diabetes or slow progression of Type 2 diabetes to markedly high blood glucose despite the treatment that they require.
Within 9 months from date of recruitment
Collection of samples for analysis of potential biomarkers
within 9 months of recruitment date
Patients with Type 2 diabetes that have been taking a second- or third-line glucose-lowering treatment (Sulphonylurea, DPP-4 inhibitors, GLP-1R agonists, SGLT2 inhibitors, Glitazone or insulin) for at least 4 months.
Patients with Type 2 diabetes that progressed to requiring insulin treatment ≤10 years from diagnosis or have had no requirement for insulin treatment \>10 years from diagnosis.
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.
University of Exeter
Exeter, Devon, EX2 5DW, United Kingdom
University of Oxford
Oxford, Oxfordshire, OX1 2JD, United Kingdom
University of Dundee
Dundee, DD1 9SY, United Kingdom
At Visit 1 a fasting blood sample (approximately 35 mls) will be taken for DNA extraction, and to measure for markers of the progression of diabetes or response to diabetes medication and for secondary markers that may predict response. A urine sample is also collected to measure for biomarkers.
Andrew T Hattersley, FRCP, DM, BM
University of Exeter
562 participants (actual enrollment reported by the registry).
First Submitted
April 8, 2014
First Posted
April 10, 2014
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
ULCERS - Electrical Stimulation in Diabetic Foot Ulceration
Contact the study team to confirm eligibility.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
June 21, 2018
Record last verified: 2018-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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