Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

• Conditions: Diabetic Nephropathy; Diabetic Retinopathy; Endothelial Dysfunction; Microalbuminuria
• Interventions: Other: non intervention

• Registration Number: NCT02409511
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Study Start: 2016-01
• Status Verified: 2016-11
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-25
• Primary Completion: 2017-09
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-diabetic, hipertension	non intervention	Non-diabetic patients with hypertension and microalbuminuria
Type 1 diabetic, retinopathy, non cardiovascular disease	non intervention	Type 1 diabetic patients with microalbuminuria, diabetic retinopathy and without cardiovascular disease
Type 2 diabetic with diabetic retinopathy	non intervention	Type 2 diabetic patients with diabetic retinopathy and microalbuminuria
Type 2 diabetic, with proven nephropathy	non intervention	Type 2 diabetic patients with biopsy proven diabetic nephropathy.
Type 2 diabetic, non diabetic retinopathy	non intervention	Type 2 diabetic patients without diabetic retinopathy and microalbuminuria

Primary Outcome Measures

Name	Time	Method
To find markers for a better definition of the meaning of microalbuminuria	3 years	Improve diagnosis of diabetic nephropathy
Complementary markers for improving the performance of MA	3 years	Improve diagnosis of diabetic nephropathy

Secondary Outcome Measures

Name	Time	Method
To identify candidates which could help to discriminate whether microalbuminuria is related to endothelial dysfunction rather than kidney damage	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.	3 years

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain