Evidence map›Paper›PMID 29850922›Full record

Trial reportDiabetologia2018

Reduced risk of heart failure with intensified multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: 21 years of follow-up in the randomised Steno-2 study.

Jens Oellgaard, Peter Gæde, Peter Rossing, Rasmus Rørth, Lars Køber, Hans-Henrik Parving, Oluf Pedersen

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

Trial report in Diabetologia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00320008 (Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria), which is not on this map. Cited by 42 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 5 pooled it
8.3field-weighted citation impact, top 2% 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.

NCT00320008 naunknown statusnot on this map

Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria

TypeinterventionalSponsorPeter GædeRan1992 to 2025Enrolled160ConditionsType 2 DiabetesArmsDiet, Exercise, Stop smoking, Glucose lowering therapy, Blood pressure lowering therapy
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 5 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Guideline
  2. Education programmes for people with chronic kidney disease and diabetes.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Review
  13. Review
  14. Article
  15. Current Position of Gliclazide and Sulfonylureas in the Contemporary Treatment Paradigm for Type 2 Diabetes: A Scoping Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Article
  16. Article
  17. Review
  18. Guardians For Health: A Practical Approach to Improving Quality of Life and Longevity in People with Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Review
  19. Review
  20. Review
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

7 authors at 3 institutions in 1 country.

Jens OellgaardDepartment of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, Denmark.
Peter GædeDepartment of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, Denmark.
Peter RossingSteno Diabetes Center Copenhagen, Gentofte, Denmark.
Rasmus RørthDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Lars KøberDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Hans-Henrik ParvingFaculty of Health, University of Copenhagen, Copenhagen, Denmark.
Oluf PedersenNovo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Blegdamsvej 3B, DK-2100, Kbh Ø, Denmark. oluf@sund.ku.dk.
Rigshospitalet · DKSlagelse Hospital · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisIn type 2 diabetes mellitus, heart failure is a frequent, potentially fatal and often forgotten complication. Glucose-lowering agents and adjuvant therapies modify the risk of heart failure. We recently reported that 7.8 years of intensified compared with conventional multifactorial intervention in individuals with type 2 diabetes and microalbuminuria in the Steno-2 study reduced the risk of cardiovascular disease and prolonged life over 21.2 years of follow-up. In this post hoc analysis, we examine the impact of intensified multifactorial intervention on the risk of hospitalisation for heart failure.

methodsOne hundred and sixty individuals were randomised to conventional or intensified multifactorial intervention, using sealed envelopes. The trial was conducted using the Prospective, Randomised, Open, Blinded Endpoints (PROBE) design. After 7.8 years, all individuals were offered intensified therapy and the study continued as an observational follow-up study for an additional 13.4 years. Heart-failure hospitalisations were adjudicated from patient records by an external expert committee blinded for treatment allocation. Event rates were compared using a Cox regression model adjusted for age and sex.

resultsEighty patients were assigned to each treatment group. Ten patients undergoing intensive therapy vs 24 undergoing conventional therapy were hospitalised for heart failure during follow-up. The HR (95% CI) was 0.30 (0.14, 0.64), p = 0.002 in the intensive-therapy group compared with the conventional-therapy group. Including death in the endpoint did not lead to an alternate overall outcome; HR 0.51 (0.34, 0.76), p = 0.001. In a pooled cohort analysis, an increase in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) during the first two years of the trial was associated with incident heart failure. CONCLUSIONS/

interpretationIntensified, multifactorial intervention for 7.8 years in type 2 diabetic individuals with microalbuminuria reduced the risk of hospitalisation for heart failure by 70% during a total of 21.2 years of observation.

trial registrationClinicalTrials.gov NCT00320008.

Indexed as

AlbuminuriaDiabetes Mellitus, Type 2Heart FailureAgedDenmarkFemaleFollow-Up StudiesHospitalizationHumansHypoglycemic AgentsMaleMiddle AgedProportional Hazards ModelsProspective StudiesRiskTime FactorsHypoglycemic AgentsComplicationsHeart failureMicroalbuminuriaMultifactorial interventionNT-proBNPType 2 diabetes

Identifiers

PMID29850922
PMCPMC6061176
OpenAlexW2806147248

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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 OpenQuestion graph.