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The WHO (World Health Organisation) estimated the prevalence of diabetes to be 422 million people in 2014, compared to 108 million in 1980. This has led to an increasing number of diabetic patients referred to nephrologists for diagnostic purposes. Diabetic nephropathy is the most common renal disease in this population and is usually a presumptive diagnosis based on clinical and biological features although microscopic examination of a renal sample acquired through renal biopsy is the only way to be certain of this diagnosis. However, kidney biopsy is an invasive procedure carrying a low but incontestable risk of adverse event such as post-procedural pain and bleeding. Consequently, nephrologist around the world feel that renal biopsy should only be performed in patients with type 2 diabetes to detect non-diabetic renal disease, when the diagnosis of diabetic nephropathy is dubious or unlikely. This likeliness is based on the presence or absence of typical feature such as diabetic retinopathy, hematuria, progressive decline of renal function or increase of proteinuria, long duration of diabetes, nephrotic syndrome. These feature were identified by the comparison of patients with type 2 diabetes and non-diabetic renal disease (alone or associated to diabetic nephropathy) and isolated diabetic nephropathy.
However, it is not known if the presence (or absence) of these atypical features by themselves are indeed signs of non-diabetic renal disease and necessitate to perform renal biopsy. The aim of the study is to determine if these atypical features are relevant indications to perform renal biopsy. To answer this question, will be analyze the medical records of patients with type 2 diabetes who underwent renal biopsy in five French nephrology center to determine, in each case, the indication of the biopsy and if this latter benefitted the patients.
In addition, will be evaluate the prognosis value of the Renal Pathology Society classification of diabetic nephropathy in patients with type 2 diabetes and diabetic nephropathy.
The purpose of the study is to evaluate the accuracy of kidney biopsies indications in patients with type 2 diabetes to diagnose non-diabetic renal disease based on canonical atypical features (Absence of diabetic retinopathy, Low or rapidly decreasing GFR, Rapidly increasing proteinuria or nephrotic syndrome and Presence of active urinary sediment. This study is a retrospective observational case only study, recruiting patients over 18 years old with type 2 diabetes who underwent kidney biopsy in five French nephrology centers between 2006 and 2015.
Will be collected demographical, clinical and biological data at the time of the renal biopsy and at the last follow-up from the patients' medical charts.
Indications for renal biopsy will be categorized as
Will be also perform a classical analysis by assessing the association of clinical and biological feature such as HbA1c, diabetes duration, absence of diabetic retinopathy,… with the presence of a non-diabetic renal disease.
In addition, the biopsy samples will be scored according to the RPS diabetic nephropathy classification to evaluate the prognostic value of this classification.
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| Measure | Description | Time Frame |
|---|---|---|
| Non-diabetic renal disease | proportion of histological diagnosisof non diabetic renal disease (with or without diabetic nephropathy) | one day |
| Measure | Description | Time Frame |
|---|---|---|
| Renal survival | Time from renal biopsy to end-stage renal disease (defined as initiation of dialysis or kidney transplantation) | one day |
| Patient survival | Patients' death and the time of this outcome from renal biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with type 2 diabetes who underwent a first renal biopsy in one of the participating centers (nephrology unit of Pontchaillou Hospital in Rennes, Conception hospital in Marseille, Bichat and Necker hospitals in Paris and Bretonneau hospital in Tours) will be included in the study unless they meet one of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Chemouny | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HM, Hôpital de la Conception | Marseille | 13005 | France | |||
| AP-HP, Hôpital Bichat-Claude Bernard |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| D003928 | Diabetic Nephropathies |
| D011507 | Proteinuria |
| D006417 | Hematuria |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| one day |
| Paris |
| 75015 |
| France |
| Rennes University Hospital | Rennes | 35000 | France |
| Hôpital Bretonneau | Tours | 37044 | France |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048909 | Diabetes Complications |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D006470 | Hemorrhage |