Evidence map›Paper›PMID 19876613›Full record

Trial reportDiabetologia2010

Determinants of urinary albumin excretion within the normal range in patients with type 2 diabetes: the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study.

E Ritz, G C Viberti, L M Ruilope, A J Rabelink, J L Izzo, S Katayama, S Ito, A Mimran, J Menne, L C Rump and 2 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetologia, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00185159 (Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00185159 phase3completednot on this map

Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)

TypeinterventionalSponsorSankyo Pharma GmbhRan2004 to 2009Enrolled4,449ConditionsDiabetes Mellitus, Type 2, Cardiovascular Disease, Kidney DiseaseArmsOlmesartan medoxomil, Placebo Tablets
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Antihypertensive agents for preventing diabetic kidney disease.The Cochrane database of systematic reviews · 2012
    Pooled it
  2. CUBN is a gene locus for albuminuria.Journal of the American Society of Nephrology : JASN · 2011
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Novel Risk Factors for Progression of Diabetic and Nondiabetic CKD: Findings From the Chronic Renal Insufficiency Cohort (CRIC) Study.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021
    Observational
  9. Article
  10. Clinical Trials on Diabetic Nephropathy: A Cross-Sectional Analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Glycated peptides are associated with proximal tubule dysfunction in type 2 diabetes mellitus.International journal of clinical and experimental medicine · 2015
    Article
  16. Article
  17. Article
  18. Observational
  19. Proteinuria and its relation to cardiovascular disease.International journal of nephrology and renovascular disease · 2013
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 11 institutions in 8 countries.

E RitzDepartment of Nephrology, University of Heidelberg, Heidelberg, Germany.
G C Viberti
L M Ruilope
A J Rabelink
J L Izzo
S Katayama
S Ito
A Mimran
J Menne
L C Rump
A Januszewicz
H Haller
Medizinische Hochschule Hannover · DEErie County Medical Center · USGuy's Hospital · GBHeidelberg University · DEHôpital Lapeyronie · FRInstitute of Cardiology · PLLeiden University Medical Center · NLResearch Institute Hospital 12 de Octubre · ESSaitama Medical University · JPTohoku University · JPUniversitätsklinik Marien Hospital Herne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisIn contrast to microalbuminuric type 2 diabetic patients, the factors correlated with urinary albumin excretion are less well known in normoalbuminuric patients. This may be important because even within the normoalbuminuric range, higher rates of albuminuria are known to be associated with higher renal and cardiovascular risk.

methodsAt the time of screening for the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) Study, the urinary albumin/creatinine ratio (UACR) was 0.44 mg/mmol in 4,449 type 2 diabetic patients. The independent correlates of UACR were analysed.

resultsIndependent correlates of UACR during baseline were (in descending order): night-time systolic BP (r(s) = 0.19); HbA(1c) (r(s) = 0.18); mean 24 h systolic BP (r(s) = 0.16); fasting blood glucose (r(s) = 0.16); night-time diastolic BP (r(s) = 0.12); office systolic BP, sitting (r(s) = 0.11), standing (r(s) = 0.10); estimated GFR (r(s) = 0.10); heart rate, sitting (r(s) = 0.10); haemoglobin (r(s) = -0.10); triacylglycerol (r(s) = 0.09); and uric acid (r(s) = -0.08; all p <or= 0.001). Significantly higher albumin excretion rates were found for the following categorical variables: higher waist circumference (more marked in men); presence of the metabolic syndrome; smoking (difference more marked in males); female sex; antihypertensive treatment; use of amlodipine; insulin treatment; family history of diabetes; and family history of cardiovascular disease (more marked in women). CONCLUSIONS/

interpretationAlthough observational correlations do not prove causality, in normoalbuminuric type 2 diabetic patients the albumin excretion rate is correlated with many factors that are potentially susceptible to intervention.

trial registrationClinicalTrials.gov ID no.: NCT00185159

fundingThis study was sponsored by Daichii-Sankyo.

Indexed as

AdolescentAdultAgedAlbuminuriaAngiotensin II Type 1 Receptor BlockersBlood PressureCreatinineDiabetes Mellitus, Type 2Double-Blind MethodElectrocardiography, AmbulatoryGlomerular Filtration RateGlycated HemoglobinHumansHypoglycemic AgentsImidazolesMiddle AgedAngiotensin II Type 1 Receptor BlockersCreatinineGlycated HemoglobinHypoglycemic AgentsImidazolesolmesartanPlacebosTetrazoles

Identifiers

PMID19876613
PMCPMC2789932
OpenAlexW2128278910

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.