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Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

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ClinicalTrials.gov Identifier: NCT02409511
Recruitment Status : Recruiting
First Posted : April 7, 2015
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Microalbuminuria Endothelial Dysfunction Diabetic Nephropathy Diabetic Retinopathy Other: non intervention

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
Estimated Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)
Study Start Date : January 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. To find markers for a better definition of the meaning of microalbuminuria [ Time Frame: 3 years ]
    Improve diagnosis of diabetic nephropathy

  2. Complementary markers for improving the performance of MA [ Time Frame: 3 years ]
    Improve diagnosis of diabetic nephropathy


Secondary Outcome Measures :
  1. To identify candidates which could help to discriminate whether microalbuminuria is related to endothelial dysfunction rather than kidney damage [ Time Frame: 3 years ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409511


Contacts
Contact: David Garcia-Dorado Garcia, PhD MD 34 93 489 40 38 dgdorado@vhebron.net

Locations
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: David Garcia-Dorado Garcia, PhD MD    34 93 489 4038    dgdorado@vhebron.net   
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         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute

Publications:
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02409511     History of Changes
Other Study ID Numbers: PRECISED Substudy
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: November 2016

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Type 1 Diabetic
Type 2 Diabetic
Hypertension
Renal Injury
Diabetic retinopathy

Additional relevant MeSH terms:
Diabetic Nephropathies
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Kidney Diseases
Urologic Diseases