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临床试验/NCT02150707
NCT02150707已完成不适用

The Differential Effects of Diabetes Therapy on Inflammation

University College Dublin1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Monocyte:chemoattractant protein 1 (MCP-1):creatinine ratio

研究概览

简要总结

This study aims to determine if different diabetes treatments have different effects on inflammation; in particular, kidney inflammation. This type of inflammation is common in people with diabetes, and can lead to kidney failure. This study will investigate the effect of different types of diabetes treatment on kidney inflammation. This will help us to decide if certain types of medicine should be preferred in people with evidence of inflammation in their kidneys, as this may help prevent major complications including kidney failure.

详细描述

In this prospective cohort study, patients who are clinically determined to require escalation of their glycaemic therapy, and prescribed a DPP4 inhibitor, GLP-1 receptor agonist, or insulin, will be invited to participate.

Blood and urine samples will be taken before, 4 to 8 weeks after, and 26 weeks after starting the new therapy. Markers of inflammation, renal function and glycemic control will be measured at each timepoint.

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
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 30 years
  • Diagnosis of type 2 diabetes for one year or more
  • Diagnosis of DKD as defined by two distinct albumin:creatinine ratio measurements above the gender specific range in the local reference laboratory with an interval of no less than eight week between measurements
  • Stable dose of an inhibitor of the renin angiotensin system for a period of 8 weeks

排除标准

  • Any cognitive impediment that preclude the participant from giving free and informed consent
  • Substance abuse including alcohol excess
  • Use of a GLP-1 analogue in the last 6 months
  • Pregnancy
  • Hypersensitivity to the prescribed treatment

研究组 & 干预措施

Dipeptidyl-Peptidase IV Inhibitors

Newly started on DPP4 inhibitor for hyperglycaemia

干预措施: Dipeptidyl-Peptidase IV Inhibitors (Drug)

Glucagon-Like Peptide 1

Newly started on GLP-1 for hyperglycaemia or obesity

干预措施: Glucagon-Like Peptide 1 (Drug)

结局指标

主要结局

Monocyte:chemoattractant protein 1 (MCP-1):creatinine ratio

时间窗: 6 months

次要结局

  • Albumin:creatinine ratio(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karl Neff

Clinical Research Fellow

University College Dublin

研究点 (1)

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