Back to resultsPrevention of Renal Failure in People Followed for Type 2 Diabetes in General Practice (PENEDIAB)
Primary Purpose
Renal Insufficiency and Diabetes Mellitus
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
training and audit
Routine care
Sponsored by
About this trial
This is an interventional prevention trial for Renal Insufficiency and Diabetes Mellitus focused on measuring diabetes mellitus, type 2, kidney diseases, primary care, prevention, early diagnosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Training
Routine care
Arm Description
Physicians participating will receive training on renal failure in type 2 diabetes and on measures to reduce nephron loss
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Audit of clinical practices
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
change of Albuminuria
Full Information
NCT ID
NCT05749679
First Posted
February 17, 2023
Last Updated
May 16, 2023
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT05749679
Brief Title
Prevention of Renal Failure in People Followed for Type 2 Diabetes in General Practice
Acronym
PENEDIAB
Official Title
Prevention of NEphronic PErt in People With Type 2 DIABETIC Disease Followed in General Practice
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency and Diabetes Mellitus
Keywords
diabetes mellitus, type 2, kidney diseases, primary care, prevention, early diagnosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Experimental
Arm Description
Physicians participating will receive training on renal failure in type 2 diabetes and on measures to reduce nephron loss
Arm Title
Routine care
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
training and audit
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
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 Outcome Measure Information:
Title
Change in annual glomerular filtration rate (GFR) slope
Description
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.
Time Frame
Every 3 months during 2 years
Secondary Outcome Measure Information:
Title
Audit of clinical practices
Time Frame
before randomization, at 6 months and 24 months in the 2 groups
Title
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)
Title
change of Albuminuria
Time Frame
at baseline and every 3 months during the 2-year follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Prevention of Renal Failure in People Followed for Type 2 Diabetes in General Practice
We'll reach out to this number within 24 hrs