Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

Diabetic Retinopathy Clinical Trial

Official title:

Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02409511
• Other study ID #: PRECISED Substudy
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2015
• Last updated: July 24, 2017
• Start date: January 2016
• Est. completion date: April 2018

Study information

• Verified date: November 2016
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: David Garcia-Dorado Garcia, PhD MD
• Phone: 34 93 489 40 38
• Email: dgdorado[@]vhebron.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Diabetic Retinopathy
• Endothelial Dysfunction
• Microalbuminuria
• Retinal Diseases

Intervention

Other:
• non intervention

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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-ß-D-glucosaminidase. Kidney Int. 2011 Feb;79(4):464-70. doi: 10.1038/ki.2010.404. Epub 2010 Oct 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To find markers for a better definition of the meaning of microalbuminuria	Improve diagnosis of diabetic nephropathy	3 years
Primary	Complementary markers for improving the performance of MA	Improve diagnosis of diabetic nephropathy	3 years
Secondary	To identify candidates which could help to discriminate whether microalbuminuria is related to endothelial dysfunction rather than kidney damage		3 years
Secondary	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