An observational study in Microalbuminuria, Endothelial Dysfunction and Diabetic Nephropathy, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-25.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational
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.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's planned enrollment of 75 is below the median of 180 across 282 observational studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
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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.
Control groups: diabetes mellitus type 1 with microalbuminuria and retinopathy hypertensive patients with microalbuminuria and diabetic patients with a renal biopsy
Exclusion Criteria:
Type 1 diabetic patients with microalbuminuria, diabetic retinopathy and without cardiovascular disease
Other: non intervention
Non-diabetic patients with hypertension and microalbuminuria
Other: non intervention
Type 2 diabetic patients without diabetic retinopathy and microalbuminuria
Other: non intervention
Type 2 diabetic patients with diabetic retinopathy and microalbuminuria
Other: non intervention
Type 2 diabetic patients with biopsy proven diabetic nephropathy.
Other: non intervention
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
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
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute