Predicting Response to Incretin Based Agents in Type 2 Diabetes (PRIBA)
Does Urinary C-peptide Creatinine Ratio Predict Response to Incretin Based Agents in Type 2 Diabetes
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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Bournmouth、イギリス、BH7 7DW
- The Royal Bournmouth and Christchurch Hospitals NHS Trust
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Bristol、イギリス、BS10 5NB
- North Bristol NHS Trust
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Ipswich、イギリス、IP4 5PD
- Ipswich Hospital NHS Trust
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Northampton、イギリス、NN15BD
- Northampton General Hospital NHS Trust
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Oxford、イギリス、OX3 9DU
- Oxford Radcliffe Hospitals NHS Trust
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Portsmouth、イギリス、PO6 3LY
- Portsmouth Hospitals NHS Trust
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Redhill、イギリス、RH1 5RH
- Surrey and Sussex Healthcare NHS Trust
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St Leonards-on-Sea、イギリス、TN37 7RD
- East Sussex Healthcare NHS Trust
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Stoke on Trent、イギリス、ST4 7LN
- University Hospitls North Staffordshire NHS Trust
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Warwick、イギリス、CV34 5BW
- South Warwickshire NHS Foundation Trust
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Watford、イギリス、WD18 0HB
- West Hertfordshire Hospitals NHS Trust
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Cornwall
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Truro、Cornwall、イギリス、TR13HD
- Cornwall and Isles of Scilly NHS Primary Care Trust
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Devon
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Barnstaple、Devon、イギリス、EX314JB
- North Devon NHS Trust
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Exeter、Devon、イギリス、EX25DW
- Royal Devon and Exeter NHS Foundation Trust
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Plymouth、Devon、イギリス、PL68DH
- Plymouth Hospitals NHS Trust
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Torbay、Devon、イギリス、TQ27AA
- South Devon Healthcare NHS Foundation Trust
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Somerset
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Taunton、Somerset、イギリス、BA228HR
- Taunton and Somerset NHS Foundation Trust.
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Yeovil、Somerset、イギリス、BA21 4AT
- Yeovil Disctrict Hospital NHS Foundation Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- A clinical diagnosis of type 2 diabetes mellitus where the patient's clinician has determined the need for a DPP-IV inhibitor or GLP-1 analogue as a result of inadequate glycaemic control
- HbA1c >= 58mmol/mol
Exclusion Criteria:
- Treatment with DPP-IV inhibitors or GLP-1 analogues prior to study initiation (within the previous 3 months)
- Renal failure as shown by a eGFR (estimated glomerular filtration rate) less than 30 mL/min/1.73m2
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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Patients starting incretin treatments
Patients starting GLP-1 agonists or DPPIV inhibitors as part of their normal clinical care.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Glycaemic response (HbA1c change post treatment)
時間枠：6 months
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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.
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6 months
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二次結果の測定
結果測定 |
時間枠 |
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Weight change over 6 months treatment
時間枠：6 months
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6 months
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協力者と研究者
捜査官
- スタディディレクター：Andrew T Hattersley、University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust
- 主任研究者：Angus Jones、University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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