Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

Conditions
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Microalbuminuria, Endothelial Dysfunction, Diabetic Nephropathy, Diabetic Retinopathy

Intervention / Treatment
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* Other: non intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients without microalbuminuria or patients with macroalbuminuria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 diabetic, retinopathy, non cardiovascular disease<br>Type 1 diabetic patients with microalbuminuria, diabetic retinopathy and without cardiovascular disease | Other: non intervention<br> <br> |
| Non-diabetic, hipertension<br>Non-diabetic patients with hypertension and microalbuminuria | Other: non intervention<br> <br> |
| Type 2 diabetic, non diabetic retinopathy<br>Type 2 diabetic patients without diabetic retinopathy and microalbuminuria | Other: non intervention<br> <br> |
| Type 2 diabetic with diabetic retinopathy<br>Type 2 diabetic patients with diabetic retinopathy and microalbuminuria | Other: non intervention<br> <br> |
| Type 2 diabetic, with proven nephropathy<br>Type 2 diabetic patients with biopsy proven diabetic nephropathy. | Other: non intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetic, Type 2 Diabetic, Hypertension, Renal Injury, Diabetic retinopathy