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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Insufficiency and Diabetes Mellitus
• Intervention / Treatment: Other: training and audit; Other: Routine care

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training; Physicians participating will receive training on renal failure in type 2 diabetes and on measures to reduce nephron loss	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 centers.10 possible actions to be deployed : Hygienic and dietary measures; Physical activity; Smoking cessation; Avoidance of nephrotoxic substances; Treatment of hypertension; Proteinuria reduction; Oral antidiabetics; choice; Optimal HBA1c; Statin; Compliance
Sham Comparator: Routine care	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 physicians will be asked to report any occurrence of adverse events to their regional pharmacovigilance centers. Physician investigators in the control group will continue their care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in annual glomerular filtration rate (GFR) slope	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.	Every 3 months during 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Audit of clinical practices	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	At 2 years (the end of the study)
change of Albuminuria	at baseline and every 3 months during the 2-year follow-up.

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: primary care; prevention; diabetes mellitus, type 2; early diagnosis; kidney diseases
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Disease; Diabetes Mellitus; Renal Insufficiency; Kidney Diseases
• Other Study ID Numbers: 2021_0864; 2022-A01698-35 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No