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临床试验/NCT01503112
NCT01503112已完成不适用

Does Urinary C-peptide Creatinine Ratio Predict Response to Incretin Based Agents in Type 2 Diabetes

Royal Devon and Exeter NHS Foundation Trust18 个研究点 分布在 1 个国家目标入组 957 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
957
试验地点
18
主要终点
Glycaemic response (HbA1c change post treatment)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Glycaemic response (HbA1c change post treatment)

时间窗: 6 months

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.

次要结局

  • Weight change over 6 months treatment(6 months)

研究者

发起方
Royal Devon and Exeter NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Angus Jones

NIHR Doctoral Research Fellow

Royal Devon and Exeter NHS Foundation Trust

研究点 (18)

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