NCT02409511

Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Microalbuminuria
• Endothelial Dysfunction
• Diabetic Nephropathy
• Diabetic Retinopathy

Interventions

Type	Name	Description
OTHER	non intervention

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-09-01
• Completion: 2018-04-01
• First posted: 2015-04-07
• Last updated: 2017-07-25

Locations

1 site across 1 country: Spain