Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

July 24, 2017 updated by: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Joan Montaner Vilallonga, PhD MD
        • Principal Investigator:
          • Rafael Simo Canonge, PhD MD
        • Principal Investigator:
          • Joan Sayos Ortega, PhD MD
        • Principal Investigator:
          • Daniel Serón Micas, PhD MD
        • Principal Investigator:
          • Joan Genesca Ferrer, PhD MD
        • Principal Investigator:
          • Santiago Aguadé Bruix, PhD MD
        • Principal Investigator:
          • Joan Xavier Comella Carnicé, PhD MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To find markers for a better definition of the meaning of microalbuminuria
Time Frame: 3 years
Improve diagnosis of diabetic nephropathy
3 years
Complementary markers for improving the performance of MA
Time Frame: 3 years
Improve diagnosis of diabetic nephropathy
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To identify candidates which could help to discriminate whether microalbuminuria is related to endothelial dysfunction rather than kidney damage
Time Frame: 3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECISED Substudy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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