Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)
NCT ID: NCT02409511
Last Updated: 2017-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
2016-01-31
2018-04-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Type 1 diabetic, retinopathy, non cardiovascular disease
Type 1 diabetic patients with microalbuminuria, diabetic retinopathy and without cardiovascular disease
non intervention
Non-diabetic, hipertension
Non-diabetic patients with hypertension and microalbuminuria
non intervention
Type 2 diabetic, non diabetic retinopathy
Type 2 diabetic patients without diabetic retinopathy and microalbuminuria
non intervention
Type 2 diabetic with diabetic retinopathy
Type 2 diabetic patients with diabetic retinopathy and microalbuminuria
non intervention
Type 2 diabetic, with proven nephropathy
Type 2 diabetic patients with biopsy proven diabetic nephropathy.
non intervention
Interventions
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non intervention
Eligibility Criteria
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Inclusion Criteria
Control groups: diabetes mellitus type 1 with microalbuminuria and retinopathy hypertensive patients with microalbuminuria and diabetic patients with a renal biopsy
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Locations
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Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Han WK, Bailly V, Abichandani R, Thadhani R, Bonventre JV. Kidney Injury Molecule-1 (KIM-1): a novel biomarker for human renal proximal tubule injury. Kidney Int. 2002 Jul;62(1):237-44. doi: 10.1046/j.1523-1755.2002.00433.x.
Huo W, Zhang K, Nie Z, Li Q, Jin F. Kidney injury molecule-1 (KIM-1): a novel kidney-specific injury molecule playing potential double-edged functions in kidney injury. Transplant Rev (Orlando). 2010 Jul;24(3):143-6. doi: 10.1016/j.trre.2010.02.002. Epub 2010 May 6.
Alter ML, Kretschmer A, Von Websky K, Tsuprykov O, Reichetzeder C, Simon A, Stasch JP, Hocher B. Early urinary and plasma biomarkers for experimental diabetic nephropathy. Clin Lab. 2012;58(7-8):659-71.
Vaidya VS, Niewczas MA, Ficociello LH, Johnson AC, Collings FB, Warram JH, Krolewski AS, Bonventre JV. Regression of microalbuminuria in type 1 diabetes is associated with lower levels of urinary tubular injury biomarkers, kidney injury molecule-1, and N-acetyl-beta-D-glucosaminidase. Kidney Int. 2011 Feb;79(4):464-70. doi: 10.1038/ki.2010.404. Epub 2010 Oct 27.
Other Identifiers
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PRECISED Substudy
Identifier Type: -
Identifier Source: org_study_id
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