Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

NCT02409511 | Unknown

• 1 other identifier: PRECISED Substudy
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Microalbuminuria; Endothelial Dysfunction; Diabetic Nephropathy; Diabetic Retinopathy

Keywords

Type 1 Diabetic; Type 2 Diabetic; Hypertension; Renal Injury; Diabetic retinopathy

Outcome Measures

Primary Outcomes (2)

• To find markers for a better definition of the meaning of microalbuminuria

  Improve diagnosis of diabetic nephropathy

  3 years

• Complementary markers for improving the performance of MA

  Improve diagnosis of diabetic nephropathy

  3 years

Secondary Outcomes (2)

• 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

Study Arms (5)

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

Interventions

non intervention OTHER

Non-diabetic, hipertension; Type 1 diabetic, retinopathy, non cardiovascular disease; Type 2 diabetic with diabetic retinopathy; Type 2 diabetic, non diabetic retinopathy; Type 2 diabetic, with proven nephropathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients without microalbuminuria or patients with macroalbuminuria

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Related Publications (4)

• 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. doi: 10.1046/j.1523-1755.2002.00433.x.

  PMID: 12081583 BACKGROUND

• 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.

  PMID: 20447817 BACKGROUND

• 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.

  PMID: 22997966 BACKGROUND

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

  PMID: 20980978 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetic Retinopathy; Hypertension

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

David Garcia-Dorado Garcia, PhD MD

CONTACT

34 93 489 40 38; dgdorado@vhebron.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 7, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: April 1, 2018
• Last Updated: July 25, 2017

Record last verified: 2016-11

Locations

ES (1)