Renal Insufficiency and Diabetes MellitusPENEDIABNCT05749679
Prevention of Renal Failure in People Followed for Type 2 Diabetes in General Practice
A study testing training and audit and Routine care in people with Renal Insufficiency and Diabetes Mellitus, run by University Hospital, Lille.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Renal Insufficiency and Diabetes Mellitus
- What is being tested?
- training and audit and Routine care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Being tested
- training and audit, Routine care
- Keywords
- diabetes mellitus, type 2, kidney diseases, primary care, prevention, early diagnosis
- Medical subject headings
- Renal Insufficiency, Diabetes Mellitus, Diabetes Mellitus, Type 2, Kidney Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training and auditOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Physicians participating will receive training on renal failure in type 2 diabetes and on measures to reduce nephron loss Receives: Other: training and audit |
| Routine care | Sham comparator | Not described Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 3 months during 2 years
Secondary outcomes (3)
Audit of clinical practices
Measured: 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
Measured: At 2 years (the end of the study)
change of Albuminuria
Measured: at baseline and every 3 months during the 2-year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study startJul 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency and Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749679
- Sponsor's protocol ID
- 2021_0864
- Other IDs
- 2022-A01698-35
- Acronym
- PENEDIAB
- Status last verified
- Dec 2025
- First submitted
- 17 Feb 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of NEphronic PErt in People With Type 2 DIABETIC Disease Followed in General Practice
- ClinicalTrials.gov ID
- NCT05749679
- Acronym / sponsor ID
- PENEDIAB / 2021_0864
- Keywords
- diabetes mellitus, type 2, kidney diseases, primary care, prevention, early diagnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: training and auditPhysicians participating will receive training on renal failure in type 2 diabetes and on measures to reduce nephron loss |
| Routine care | Sham comparator | Other: Routine care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| training and auditAn 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 | Other | Training |
| Routine carePhysicians 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. | Other | Routine care |
Primary outcome
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.
3 secondary outcomes
Audit of clinical practices
Time frame: 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
Time frame: At 2 years (the end of the study)
change of Albuminuria
Time frame: at baseline and every 3 months during the 2-year follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing training and audit and Routine care in people with Renal Insufficiency and Diabetes Mellitus, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in annual glomerular filtration rate (GFR) slope (time frame: Every 3 months during 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.