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治験 NCT01503112 (PRIBA)（対象：2型糖尿病）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Predicting Response to Incretin Based Agents in Type 2 Diabetes (PRIBA) 957
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT01503112 (PRIBA) は 観察研究 臨床試験 で、2型糖尿病 を対象とした研究でした。現在は 完了 です。2011年5月1日 に開始し、957 名の参加者 が参加しました。この試験は Royal Devon and Exeter NHS Foundation Trust によって主導され、2014年4月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2018年4月19日 です。
概要
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 w...もっと見る
公式タイトル
Does Urinary C-peptide Creatinine Ratio Predict Response to Incretin Based Agents in Type 2 Diabetes
疾患名
2型糖尿病刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- PRIBA
- 11233581
NCT番号
開始日
2011-05
最終更新日
2018-04-19
終了予定日
2014-04
目標参加者数
957
試験の種類
観察研究
状況
完了
キーワード
Glucagon-Like Peptide 1, DPP4 protein, Therapeutics, Hypoglycemic Agents, C-Peptide, Type 2 Diabetes Mellitus,
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Patients starting incretin treatments Patients starting GLP-1 agonists or DPPIV inhibitors as part of their normal clinical care. | 介入なし、観察研究 |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Weight change over 6 months treatment | 6 months |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- 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
- 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
Royal Devon and Exeter NHS Foundation Trust- National Institute for Health Research, United Kingdom
- University of Exeter
責任者
Angus Jones, 主任研究者, NIHR Doctoral Research Fellow, Royal Devon and Exeter NHS Foundation Trust
連絡先情報がありません。
18 1カ国の場所
Cornwall
Cornwall and Isles of Scilly NHS Primary Care Trust, Truro, Cornwall, TR13HD, United Kingdom
Devon
North Devon NHS Trust, 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
Somerset
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