Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

Hospital Universitari Vall d'Hebron Research Institute75 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Microalbuminuria Endothelial Dysfunction Diabetic Nephropathy Diabetic Retinopathy

Interventions

non interventionOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

To find markers for a better definition of the meaning of microalbuminuria

Improve diagnosis of diabetic nephropathy

Time frame: 3 years

Complementary markers for improving the performance of MA

Improve diagnosis of diabetic nephropathy

Time frame: 3 years

Secondary Outcomes

To identify candidates which could help to discriminate whether microalbuminuria is related to endothelial dysfunction rather than kidney damage

Time frame: 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.

Time frame: 3 years

Central Contacts

David Garcia-Dorado Garcia, PhD MD

CONTACT

34 93 489 40 38 dgdorado@vhebron.net

Data from ClinicalTrials.gov

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