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

NCT ID: NCT05749679

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-31
• Study Completion Date: 2027-07-31

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.

Conditions

Renal Insufficiency and Diabetes Mellitus

Keywords

diabetes mellitus, type 2; kidney diseases; primary care; prevention; early diagnosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Training

Physicians participating will receive training on renal failure in type 2 diabetes and on measures to reduce nephron loss

Group Type: EXPERIMENTAL

training and audit

Intervention Type: OTHER

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 :

1. Hygienic and dietary measures

2. Physical activity

3. Smoking cessation

4. Avoidance of nephrotoxic substances

5. Treatment of hypertension

6. Proteinuria reduction

7. Oral antidiabetics; choice

8. Optimal HBA1c

9. Statin

10. Compliance

Routine care

Group Type: SHAM_COMPARATOR

Routine care

Intervention Type: OTHER

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.

Interventions

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 :

1. Hygienic and dietary measures

2. Physical activity

3. Smoking cessation

4. Avoidance of nephrotoxic substances

5. Treatment of hypertension

6. Proteinuria reduction

7. Oral antidiabetics; choice

8. Optimal HBA1c

9. Statin

10. Compliance

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2022-A01698-35

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0864

Identifier Type: -

Identifier Source: org_study_id