---
title: Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)
nct_id: NCT02409511
overall_status: UNKNOWN
sponsor: "Hospital Universitari Vall d'Hebron Research Institute"
study_type: OBSERVATIONAL
primary_condition: Microalbuminuria
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02409511.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02409511"
ct_last_update_post_date: 2017-07-25
last_seen_at: "2026-05-12T06:33:42.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

**NCT ID:** [NCT02409511](https://clinicaltrials.gov/study/NCT02409511)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 75
- **Lead Sponsor:** Hospital Universitari Vall d'Hebron Research Institute
- **Conditions:** Microalbuminuria, Endothelial Dysfunction, Diabetic Nephropathy, Diabetic Retinopathy
- **Start Date:** 2016-01
- **Completion Date:** 2018-04
- **CT.gov Last Update:** 2017-07-25

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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
```

## Arms

- **Type 1 diabetic, retinopathy, non cardiovascular disease** — Type 1 diabetic patients with microalbuminuria, diabetic retinopathy and without cardiovascular disease
- **Non-diabetic, hipertension** — Non-diabetic patients with hypertension and microalbuminuria
- **Type 2 diabetic, non diabetic retinopathy** — Type 2 diabetic patients without diabetic retinopathy and microalbuminuria
- **Type 2 diabetic with diabetic retinopathy** — Type 2 diabetic patients with diabetic retinopathy and microalbuminuria
- **Type 2 diabetic, with proven nephropathy** — Type 2 diabetic patients with biopsy proven diabetic nephropathy.

## Interventions

- **non intervention** (OTHER)

## Primary Outcomes

- **To find markers for a better definition of the meaning of microalbuminuria** _(time frame: 3 years)_ — Improve diagnosis of diabetic nephropathy
- **Complementary markers for improving the performance of MA** _(time frame: 3 years)_ — Improve diagnosis of diabetic nephropathy

## Secondary Outcomes

- **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)_

## Locations (1)

- Hospital Universitari Vall d'Hebron, Barcelona, Spain — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital universitari vall d'hebron|barcelona||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02409511.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02409511*  
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