MicroalbuminuriaNCT02409511
Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)
An observational study of Microalbuminuria and Endothelial Dysfunction, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microalbuminuria, Endothelial Dysfunction, Diabetic Nephropathy
- What is being tested?
- non intervention
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients without microalbuminuria or patients with macroalbuminuria
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
David Garcia-Dorado Garcia, PhD MD, 34 93 489 4038, dgdorado@vhebron.net
Joan Montaner Vilallonga, PhD MD
About this study
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.
Read the 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.
- Being tested
- non intervention
- Keywords
- Type 1 Diabetic, Type 2 Diabetic, Hypertension, Renal Injury, Diabetic retinopathy
- Medical subject headings
- Diabetic Nephropathies, Diabetic Retinopathy, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetic, retinopathy, non cardiovascular disease | Type 1 diabetic patients with microalbuminuria, diabetic retinopathy and without cardiovascular disease Receives: Other: non intervention | |
| Non-diabetic, hipertension | Non-diabetic patients with hypertension and microalbuminuria Receives: Other: non intervention | |
| Type 2 diabetic, non diabetic retinopathy | Type 2 diabetic patients without diabetic retinopathy and microalbuminuria Receives: Other: non intervention | |
| Type 2 diabetic with diabetic retinopathy | Type 2 diabetic patients with diabetic retinopathy and microalbuminuria Receives: Other: non intervention | |
| Type 2 diabetic, with proven nephropathy | Type 2 diabetic patients with biopsy proven diabetic nephropathy. Receives: Other: non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To find markers for a better definition of the meaning of microalbuminuria
Improve diagnosis of diabetic nephropathy
Measured: 3 years
Complementary markers for improving the performance of MA
Improve diagnosis of diabetic nephropathy
Measured: 3 years
Secondary outcomes (2)
To identify candidates which could help to discriminate whether microalbuminuria is related to endothelial dysfunction rather than kidney damage
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MicroalbuminuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409511
- Sponsor's protocol ID
- PRECISED Substudy
- Status last verified
- Nov 2016
- First submitted
- 1 Apr 2015
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12081583Huo 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.
PubMed 20447817Alter 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.
PubMed 22997966Vaidya 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.
PubMed 20980978
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)
- ClinicalTrials.gov ID
- NCT02409511
- Acronym / sponsor ID
- PRECISED Substudy
- Keywords
- Type 1 Diabetic, Type 2 Diabetic, Hypertension, Renal Injury, Diabetic retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetic, retinopathy, non cardiovascular disease | – | Other: non interventionType 1 diabetic patients with microalbuminuria, diabetic retinopathy and without cardiovascular disease |
| Non-diabetic, hipertension | – | Other: non interventionNon-diabetic patients with hypertension and microalbuminuria |
| Type 2 diabetic, non diabetic retinopathy | – | Other: non interventionType 2 diabetic patients without diabetic retinopathy and microalbuminuria |
| Type 2 diabetic with diabetic retinopathy | – | Other: non interventionType 2 diabetic patients with diabetic retinopathy and microalbuminuria |
| Type 2 diabetic, with proven nephropathy | – | Other: non interventionType 2 diabetic patients with biopsy proven diabetic nephropathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients without microalbuminuria or patients with macroalbuminuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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
2 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Background: PubMed 12081583Han 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.
- Background: PubMed 20447817Huo 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.
- Background: PubMed 22997966Alter 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.
- Background: PubMed 20980978Vaidya 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.
Related trials for Microalbuminuria
Not yet recruitingObservational study
Diastolic Dysfunction and Pulmonary Hypertension in T2DM With Microalbuminuria
Diabetes Mellitus Type 2
RecruitingPhase 1
Time Restricted Eating in Patients With Microalbuminuria
Type 2 Diabetes Mellitus (T2DM), Time Restricted Eating
Recruiting
New Taipei City 888 Digital Medical AI Platform for Prevention and Care of the Three Highs and Cardio-Renal-Vascular Diseases
Microalbuminuria, Microalbuminuria /Creatinine Ratios ACR
RecruitingPhase 4
ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases
Hypertensive Nephropathy, Auto Immune Disorders
Enrolling by invitationObservational study
Risk Factors at Chronic Non-communicable Diseases in People of Working Age
Chronic Non-communicable Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microalbuminuria and Endothelial Dysfunction, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Garcia-Dorado Garcia, PhD MD (34 93 489 40 38, dgdorado@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find markers for a better definition of the meaning of microalbuminuria (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409511, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.