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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| University of Exeter | OTHER |
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Type 2 diabetes is a major and rapidly increasing health problem worldwide. Keeping the blood glucose (sugar) from going too high helps prevent complications. Recently a number of new treatments (collectively called 'incretin based' treatments) to lower blood glucose have become available but response is very variable and it is difficult to predict which will work for an individual. The investigators want to see if we can identify whether the new treatments are likely to be effective for an individual patient. Identifying the right treatment would improve control and minimise the side-effects and costs from ineffective treatments. We will collect blood (for measures of blood glucose, insulin secretion and genetics information), urine (for a simple measurement of insulin secretion) and other clinical information (such as weight,age, duration of diabetes and medication) in people who are about to start these new 'incretin based' treatments and assess their response over the first 6 months of treatment. We will analyse this information to see if we can predict treatment response.
Study Hypothesis:
The investigators hypothesise that those who have low insulin secretion, as measured by post meal urine C-peptide Creatinine Ratio or blood C-peptide, will have poor blood glucose response to incretin based treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients starting incretin treatments | Patients starting GLP-1 agonists or DPPIV inhibitors as part of their normal clinical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention, observational study | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemic response (HbA1c change post treatment) | Change in HbA1c over 6 months treatment (as a continuous variable and/or defined as binary response/non response). Our Primary analysis will be the relationship between insulin secretion (as measured by blood C-peptide or UCPCR) and glycaemic response. Secondary analysis will include examination of relationship between baseline weight, HbA1c, age, duration of diabetes, HOMA B, HOMA IR, autoantibody (GAD, IA2) status and glycaemic response. We will also examine the relationship between glycaemic response and polymorphisms in GLP-1R, TCF7L2, WFS1 and FOX01 genes. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change over 6 months treatment | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with type 2 Diabetes commencing DPP-IV inhibitors or GLP-1 agonsists in primary or secondary care in England
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| Name | Affiliation | Role |
|---|---|---|
| Andrew T Hattersley | University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust | Study Director |
| Angus Jones | University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornwall and Isles of Scilly NHS Primary Care Trust | Truro | Cornwall | TR13HD | United Kingdom | ||
| North Devon NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26242184 | Result | Jones AG, McDonald TJ, Shields BM, Hill AV, Hyde CJ, Knight BA, Hattersley AT; PRIBA Study Group. Markers of beta-Cell Failure Predict Poor Glycemic Response to GLP-1 Receptor Agonist Therapy in Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):250-7. doi: 10.2337/dc15-0258. Epub 2015 Aug 4. | |
| 29386249 | Result | Dennis JM, Shields BM, Hill AV, Knight BA, McDonald TJ, Rodgers LR, Weedon MN, Henley WE, Sattar N, Holman RR, Pearson ER, Hattersley AT, Jones AG; MASTERMIND Consortium. Precision Medicine in Type 2 Diabetes: Clinical Markers of Insulin Resistance Are Associated With Altered Short- and Long-term Glycemic Response to DPP-4 Inhibitor Therapy. Diabetes Care. 2018 Apr;41(4):705-712. doi: 10.2337/dc17-1827. Epub 2018 Jan 31. |
| Label | URL |
|---|---|
| Research group website | View source |
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Extracted DNA, stored serum/plasma
| Barnstaple |
| Devon |
| EX314JB |
| United Kingdom |
| Royal Devon and Exeter NHS Foundation Trust | Exeter | Devon | EX25DW | United Kingdom |
| Plymouth Hospitals NHS Trust | Plymouth | Devon | PL68DH | United Kingdom |
| South Devon Healthcare NHS Foundation Trust | Torbay | Devon | TQ27AA | United Kingdom |
| Taunton and Somerset NHS Foundation Trust. | Taunton | Somerset | BA228HR | United Kingdom |
| Yeovil Disctrict Hospital NHS Foundation Trust | Yeovil | Somerset | BA21 4AT | United Kingdom |
| The Royal Bournmouth and Christchurch Hospitals NHS Trust | Bournmouth | BH7 7DW | United Kingdom |
| North Bristol NHS Trust | Bristol | BS10 5NB | United Kingdom |
| Ipswich Hospital NHS Trust | Ipswich | IP4 5PD | United Kingdom |
| Northampton General Hospital NHS Trust | Northampton | NN15BD | United Kingdom |
| Oxford Radcliffe Hospitals NHS Trust | Oxford | OX3 9DU | United Kingdom |
| Portsmouth Hospitals NHS Trust | Portsmouth | PO6 3LY | United Kingdom |
| Surrey and Sussex Healthcare NHS trust | Redhill | RH1 5RH | United Kingdom |
| East Sussex Healthcare NHS Trust | Saint Leonards-on-Sea | TN37 7RD | United Kingdom |
| University Hospitls North Staffordshire NHS Trust | Stoke-on-Trent | ST4 7LN | United Kingdom |
| South Warwickshire NHS Foundation Trust | Warwick | CV34 5BW | United Kingdom |
| West Hertfordshire Hospitals NHS Trust | Watford | WD18 0HB | United Kingdom |
| 25340784 | Result | Jones AG, Shields BM, Hyde CJ, Henley WE, Hattersley AT. Identifying good responders to glucose lowering therapy in type 2 diabetes: implications for stratified medicine. PLoS One. 2014 Oct 23;9(10):e111235. doi: 10.1371/journal.pone.0111235. eCollection 2014. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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