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Microalbuminuria (MA) is an independent cardiovascular risk factor in diabetic and non-diabetic subjects.
However, in the setting of type 2 diabetes, microalbuminuria could be a marker of either early diabetic nephropathy or diffuse endothelial dysfunction. At present, there are no biomarkers that permit us to discriminate between these two conditions.
A hypothesis free approach by using proteomic/metabolomic analyses in the urine samples of selected populations seems an appropriate approach by which to explore this issue. In addition, a driven hypothesis in the same groups of patients based on a sensitive marker of kidney injury also seems appropriate.
Urinary levels of KIM-1(Kidney Injury Molecule-1 ) have been found elevated in experimental diabetic nephropathy even before that MA . In addition, urinary levels of KIM-1 were found significantly elevated in type 1 diabetic patients with MA, in comparison with diabetics with normoalbuminuria and non-diabetic healthy controls. Moreover, low urinary KIM-1 levels at baseline were associated with the regression of MA during a follow-up of 2 years . Therefore, it could be hypothesized that the presence of MA + KIM-1 in urine samples would indicate renal injury rather than endothelial dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 diabetic, retinopathy, non cardiovascular disease | Type 1 diabetic patients with microalbuminuria, diabetic retinopathy and without cardiovascular disease |
| |
| Non-diabetic, hipertension | Non-diabetic patients with hypertension and microalbuminuria |
| |
| Type 2 diabetic, non diabetic retinopathy | Type 2 diabetic patients without diabetic retinopathy and microalbuminuria |
| |
| Type 2 diabetic with diabetic retinopathy | Type 2 diabetic patients with diabetic retinopathy and microalbuminuria |
| |
| Type 2 diabetic, with proven nephropathy | Type 2 diabetic patients with biopsy proven diabetic nephropathy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| To find markers for a better definition of the meaning of microalbuminuria | Improve diagnosis of diabetic nephropathy | 3 years |
| Complementary markers for improving the performance of MA | Improve diagnosis of diabetic nephropathy | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To identify candidates which could help to discriminate whether microalbuminuria is related to endothelial dysfunction rather than kidney damage | 3 years | |
| To test whether the enhancement of this specific marker of kidney injury is able to identify those patients in which MA really means diabetic nephropathy. |
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Inclusion Criteria:
Control groups: diabetes mellitus type 1 with microalbuminuria and retinopathy hypertensive patients with microalbuminuria and diabetic patients with a renal biopsy
Exclusion Criteria:
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Adult patients with diabetes mellitus type 2 with microalbuminuria with and without retinopathy.
Control groups: diabetes mellitus type 1 with microalbuminuria and retinopathy hypertensive patients with microalbuminuria and diabetic patients with a renal biopsy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Garcia-Dorado Garcia, PhD MD | Contact | 34 93 489 40 38 | dgdorado@vhebron.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12081583 | Background | Han WK, Bailly V, Abichandani R, Thadhani R, Bonventre JV. Kidney Injury Molecule-1 (KIM-1): a novel biomarker for human renal proximal tubule injury. Kidney Int. 2002 Jul;62(1):237-44. doi: 10.1046/j.1523-1755.2002.00433.x. | |
| 20447817 | Background | Huo W, Zhang K, Nie Z, Li Q, Jin F. Kidney injury molecule-1 (KIM-1): a novel kidney-specific injury molecule playing potential double-edged functions in kidney injury. Transplant Rev (Orlando). 2010 Jul;24(3):143-6. doi: 10.1016/j.trre.2010.02.002. Epub 2010 May 6. |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003930 | Diabetic Retinopathy |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 3 years |
| 22997966 | Background | Alter ML, Kretschmer A, Von Websky K, Tsuprykov O, Reichetzeder C, Simon A, Stasch JP, Hocher B. Early urinary and plasma biomarkers for experimental diabetic nephropathy. Clin Lab. 2012;58(7-8):659-71. |
| 20980978 | Background | Vaidya VS, Niewczas MA, Ficociello LH, Johnson AC, Collings FB, Warram JH, Krolewski AS, Bonventre JV. Regression of microalbuminuria in type 1 diabetes is associated with lower levels of urinary tubular injury biomarkers, kidney injury molecule-1, and N-acetyl-beta-D-glucosaminidase. Kidney Int. 2011 Feb;79(4):464-70. doi: 10.1038/ki.2010.404. Epub 2010 Oct 27. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |