Prevention of Renal Failure in People Followed for Type 2 Diabetes in General Practice

Официальное название

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

Обзор

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.

Вмешательства

• Другое training and audit
  An evaluation of the practices with clinical audit before and after the management will be carried out.Every 3 months for 2 years, the investigating physicians of the intervention group will report for these patients the modifications or cessation of treatment, modification or implementation of interventions such as physical activity or implementation of nutritional modifications. Physician investigators will be asked to report any occurrence of adverse events to their regional pharmacovigilance
• Другое Routine care
  Physicians in the "control" group will receive training on the study procedures. An evaluation of practices with a clinical audit before and after the treatments will be carried out. Every 3 months for 2 years, the investigating physicians in the control group will report for these patients the modifications or cessation of treatment, the modification or implementation of interventions such as physical activity or the implementation of modifications in terms of nutrition. The investigating physi

Первичные конечные точки

• Change in annual glomerular filtration rate (GFR) slope [Срок оценки: Every 3 months during 2 years]

Вторичные конечные точки (3)

• Audit of clinical practices [Срок оценки: before randomization, at 6 months and 24 months in the 2 groups]
• 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 [Срок оценки: At 2 years (the end of the study)]
• change of Albuminuria [Срок оценки: at baseline and every 3 months during the 2-year follow-up.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05749679 · 2021_0864 · 2022-A01698-35

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗