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Not yet recruiting NCT05749679

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

No phase Interventional Renal Insufficiency and Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: training and audit, Routine care.
Who it may be relevant to
Registry conditions: Renal Insufficiency and Diabetes Mellitus. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other 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
  • Other 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

Primary outcome measures

  • Change in annual glomerular filtration rate (GFR) slope [Time frame: Every 3 months during 2 years]
Secondary outcome measures (3)
  • Audit of clinical practices [Time frame: 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 [Time frame: At 2 years (the end of the study)]
  • change of Albuminuria [Time frame: at baseline and every 3 months during the 2-year follow-up.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗