Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Diabetic Nephropathy; Endothelial Dysfunction; Microalbuminuria; Diabetic Retinopathy

Treatments: Other: non intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02409511

PRECISED Substudy

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 5 patient groups

Type 1 diabetic, retinopathy, non cardiovascular disease

Description:

Type 1 diabetic patients with microalbuminuria, diabetic retinopathy and without cardiovascular disease

Treatment:

Other: non intervention

Non-diabetic, hipertension

Description:

Non-diabetic patients with hypertension and microalbuminuria

Treatment:

Other: non intervention

Type 2 diabetic, non diabetic retinopathy

Description:

Type 2 diabetic patients without diabetic retinopathy and microalbuminuria

Treatment:

Other: non intervention

Type 2 diabetic with diabetic retinopathy

Description:

Type 2 diabetic patients with diabetic retinopathy and microalbuminuria

Treatment:

Other: non intervention

Type 2 diabetic, with proven nephropathy

Description:

Type 2 diabetic patients with biopsy proven diabetic nephropathy.

Treatment:

Other: non intervention