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Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02409511
Enrollment
75
Registered
2015-04-07
Start date
2016-01-31
Completion date
2018-04-30
Last updated
2017-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy, Diabetic Retinopathy, Endothelial Dysfunction, Microalbuminuria

Keywords

Type 1 Diabetic, Type 2 Diabetic, Hypertension, Renal Injury, Diabetic retinopathy

Brief 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.

Interventions

OTHERnon intervention

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To find markers for a better definition of the meaning of microalbuminuria3 yearsImprove diagnosis of diabetic nephropathy
Complementary markers for improving the performance of MA3 yearsImprove diagnosis of diabetic nephropathy

Secondary

MeasureTime frame
To identify candidates which could help to discriminate whether microalbuminuria is related to endothelial dysfunction rather than kidney damage3 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

Countries

Spain

Contacts

Primary ContactDavid Garcia-Dorado Garcia, PhD MD
dgdorado@vhebron.net34 93 489 40 38

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026