Prevention of NEphronic PErt in People With Type 2 DIABETIC Disease Followed in General Practice

University Hospital, Lille0 个研究点目标入组 360 人开始时间: 2026年7月1日最近更新: 2025年12月26日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 360
主要终点: Change in annual glomerular filtration rate (GFR) slope

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This work will make it possible to identify the nephron loss of type 2 diabetic patients in the western region and to better define in general practice the impact of the elements put in place to reduce this loss and to raise awareness of the importance of these measures through training in comparison with a control group.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 50 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patient consulting his or her investigating general practitioner
•50 years old or more
•type 2 diabetic for more than 5 years, with a GFR lower than 90 ml/mn and higher than 45 ml/mn (stage 2 and 3a of renal failure) and a nephron loss calculated on the average of the two previous years, higher than 3 ml/mn/year
•a microalbuminuria > 30 mg/gr of creatinuria.
•Having declared the investigator as the treating physician

排除标准

•Patient under 50 years of age Patients who do not agree to the use of their data (refusal of consent) or are unable to give consent (dementia, other) Patients with other types of diabetes Patients with renal failure other than diabetic or hypertensive glomerulopathy Patients unable to give consent Patients who do not understand the French language Patients with less than 3 months of planned follow-up Patients with a barrier to follow-up Patients undergoing dialysis, transplantation

结局指标

主要结局

Change in annual glomerular filtration rate (GFR) slope

时间窗: Every 3 months during 2 years

the annual glomerular filtration rate (GFR) slope calculated as the difference between the estimated loss over the two years before inclusion (N-2) and the estimated annual loss over the follow-up years after inclusion.

次要结局

Audit of clinical practices(before randomization, at 6 months and 24 months in the 2 groups)
change of Albuminuria(at baseline and every 3 months during the 2-year follow-up.)
Cumulative incidence of unscheduled hospitalizations for all reasons at 2 years from the start of care in the intervention group compared to the control group(At 2 years (the end of the study))

研究者

发起方

University Hospital, Lille

申办方类型

Other

责任方

Sponsor

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