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

NCT05749679 | Not Yet Recruiting

• 2 other identifiers: 2021_08642022-A01698-35
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (2)

Training

EXPERIMENTAL

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

Other: training and audit

Routine care

SHAM COMPARATOR

Other: Routine care

Interventions

training and audit 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

Training

Routine care 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.

Routine care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient consulting his or her investigating general practitioner
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2; Kidney Diseases; Disease

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 1, 2023
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12