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Clinical Trials/NCT05749679
NCT05749679
Not yet recruiting
Not Applicable

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

University Hospital, Lille0 sites360 target enrollmentJuly 1, 2026

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Insufficiency and Diabetes Mellitus
Sponsor
University Hospital, Lille
Enrollment
360
Primary Endpoint
Change in annual glomerular filtration rate (GFR) slope
Status
Not yet recruiting
Last Updated
4 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2026
End Date
July 1, 2027
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in annual glomerular filtration rate (GFR) slope

Time Frame: 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.

Secondary Outcomes

  • 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))

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