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

Not Applicable

Not yet recruiting

• Conditions: Renal Insufficiency and Diabetes Mellitus
• Interventions: Other: Routine care; Other: training and audit

• Registration Number: NCT05749679
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-18
• Study Start: 2023-07
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine care	Routine care	-
Training	training and audit	Physicians participating will receive training on renal failure in type 2 diabetes and on measures to reduce nephron loss

Primary Outcome Measures

Name	Time	Method
Change in annual glomerular filtration rate (GFR) slope	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 Outcome Measures

Name	Time	Method
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)