Prevention of NEphron loss in type 2 DIABetic patients followed in general practice. Protocol of the French PENEDIAB study

Gabrielle Lisembard, Sabine Bayen, Pierre Fontaine, Francois Glowacki, François Quersin, Alissa Sebbah, Marc Bayen
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Abstract

Background

The number of diabetic patients is constantly increasing in France. The severity of long-term diabetes is linked to the complications it causes, including renal failure. GFR decline is a good means of measuring a loss of renal function. General practitioners (GPs) are in the front line concerning the global accompaniment of these patients. This includes prevention, follow-up, therapeutical adaptation.

Purpose

To identify GFR decline diabetic patients and the impact of implemented measures in general practice to reduce this loss.

Materials and methods

We present the protocol of a prospective, multicentred, randomized, controlled, two-arm interventional study amongst a study population in the North-West region of France. The 360 types 2 diabetic patients will be recruited by 36 GPs. The inclusion criteria target women or men over 50 with type 2 diabetes, and GFR less than 90 ml/min and greater than 45 ml/min (stage 2 and 3a renal failure). 18 GPs will be randomized in an intervention group (training on GFR decline screening and specific patient-centred measures). The study is promoted by the University Hospital of Lille. The main objective of the study is to demonstrate that patient-adapted preventive management reduces GFR decline in type 2 diabetic patients.

Expected results

To improve the patients’ quality of life through the early screening any study on GFR decline should involve GPs since they do have a preventive role in general practice and avoid renal failure.

Conclusion

Up to now, in France, any study on GFR decline should involve GPs since they do have a preventive role

预防2型糖尿病患者的NEphron丢失在全科医学中遵循。法国PENEDIAB研究的议定书
背景法国糖尿病患者的数量不断增加。长期糖尿病的严重程度与其引起的并发症有关,包括肾衰竭。肾小球滤过率下降是衡量肾功能丧失的一个好方法。全科医生站在关注这些患者全球陪伴的第一线。这包括预防、随访、治疗适应。目的确定肾小球滤过率下降的糖尿病患者,以及在全科医学中实施措施以减少这种损失的影响。材料和方法我们在法国西北地区的一个研究人群中提出了一项前瞻性、多中心、随机、对照、双臂介入研究的方案。360名2型糖尿病患者将由36名全科医生招募。纳入标准针对50岁以上患有2型糖尿病、肾小球滤过率低于90毫升/分钟且大于45毫升/分钟(2期和3a期肾衰竭)的女性或男性。18名全科医生将被随机分为一个干预组(GFR下降筛查和以患者为中心的具体措施培训)。这项研究是由里尔大学医院推动的。该研究的主要目的是证明患者适应的预防性管理可以降低2型糖尿病患者的肾小球滤过率下降。预期结果为了通过早期筛查提高患者的生活质量,任何关于肾小球滤过率下降的研究都应该涉及全科医生,因为他们在全科医学中确实具有预防作用,可以避免肾衰竭。结论到目前为止,在法国,任何关于肾小球滤过率下降的研究都应该涉及全科医生,因为他们确实具有预防作用
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