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NCT Number: NCT05749679

Prevention of Renal Failure in People Followed for Type 2 Diabetes 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.

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Key information

Conditions

Renal Insufficiency and Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 :

  • Hygienic and dietary measures
  • Physical activity
  • Smoking cessation
  • Avoidance of nephrotoxic substances
  • Treatment of hypertension
  • Proteinuria reduction
  • Oral antidiabetics; choice
  • Optimal HBA1c
  • Statin
  • Compliance

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.

Primary outcomes

  1. 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

  1. Audit of clinical practices

    Time frame: before randomization, at 6 months and 24 months in the 2 groups

  2. 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

    Time frame: At 2 years (the end of the study)

  3. change of Albuminuria

    Time frame: at baseline and every 3 months during the 2-year follow-up.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: PENEDIAB

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 1, 2023
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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