Evidence map›Paper›PMID 34330770›Full record

Trial reportJournal of the American Society of Nephrology : JASN2021

Early Postoperative Basal Insulin Therapy versus Standard of Care for the Prevention of Diabetes Mellitus after Kidney Transplantation: A Multicenter Randomized Trial.

Elisabeth Schwaiger, Simon Krenn, Amelie Kurnikowski, Leon Bergfeld, María José Pérez-Sáez, Alexander Frey, David Topitz, Michael Bergmann, Sebastian Hödlmoser, Friederike Bachmann and 15 more

Open access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
4.9field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 39 citations in OpenAlex.

  1. Trial
  2. Criteria for prediabetes and posttransplant diabetes mellitus after kidney transplantation: A 2-year diagnostic accuracy study of participants from a randomized controlled trial.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022
    Trial
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. International consensus on post-transplantation diabetes mellitus.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2024
    Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 10 institutions in 5 countries.

Elisabeth SchwaigerDepartment of Internal Medicine III, Medical University of Vienna, Vienna, Austria.ORCID 0000-0002-1718-274X
Amelie KurnikowskiDepartment of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
Leon BergfeldDepartment of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
María José Pérez-SáezDepartment of Nephrology, Hospital del Mar, Barcelona, Spain.
Alexander FreyDepartment of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
David TopitzDepartment of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
Michael BergmannDepartment of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
Sebastian HödlmoserDepartment of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
Friederike BachmannDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Berlin, Germany.
Fabian HalleckDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Berlin, Germany.
Susanne KronDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Berlin, Germany.
Hildegard Hafner-GiessaufDepartment of Internal Medicine, Medical University of Graz, Graz, Austria.
Alexander R RosenkranzDepartment of Internal Medicine, Medical University of Graz, Graz, Austria.
Anna FauraDepartment of Nephrology, Hospital del Mar, Barcelona, Spain.
Andrea TuraMetabolic Unit, CNR Institute of Neuroscience, Padova, Italy.
Peter X K SongDepartment of Biostatistics, University of Michigan, Ann Arbor, Michigan.
Friedrich K PortArbor Research Collaborative for Health, Ann Arbor, Michigan.
Julio PascualDepartment of Nephrology, Hospital del Mar, Barcelona, Spain.
Robin RistlCenter for Medical Statistics, Informatics and Intelligent Systems, Vienna, Austria.
Johannes Werzowa1st Medical Department, Ludwig Boltzmann Institute of Osteology at the Hanusch Hospital of WGKK and AUVA Trauma Center Meidling, Vienna, Austria.
Manfred HeckingDepartment of Internal Medicine III, Medical University of Vienna, Vienna, Austria manfred.hecking@meduniwien.ac.at.ORCID 0000-0002-8047-2395
Medical University of Vienna · ATCharité - Universitätsmedizin Berlin · DEHospital Del Mar · ESMedical University of Graz · ATArbor Research Collaborative for Health · USHanusch Hospital · ATKepler Universitätsklinikum · ATNeuroscience Institute · ITStatistics Austria · ATUniversity of Michigan · US

Funding

A Clinical Trial to Prevent New Onset Diabetes After TransplantationR01DK092475 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI OJO, AKINLOLU OLUSEUN · 2011 to 2014
$1.9M
NIDDK NIH HHS R01 DK092475
6 · The paper itself

Abstract

backgroundPost-transplantation diabetes mellitus (PTDM) might be preventable.

methodsThis open-label, multicenter randomized trial compared 133 kidney transplant recipients given intermediate-acting insulin isophane for postoperative afternoon glucose ≥140 mg/dl with 130 patients given short-acting insulin for fasting glucose ≥200 mg/dl (control). The primary end point was PTDM (antidiabetic treatment or oral glucose tolerance test-derived 2 hour glucose ≥200 mg/dl) at month 12 post-transplant.

resultsIn the intention-to-treat population, PTDM rates at 12 months were 12.2% and 14.7% in treatment versus control groups, respectively (odds ratio [OR], 0.82; 95% confidence interval [95% CI], 0.39 to 1.76) and 13.4% versus 17.4%, respectively, at 24 months (OR, 0.71; 95% CI, 0.34 to 1.49). In the per-protocol population, treatment resulted in reduced odds for PTDM at 12 months (OR, 0.40; 95% CI, 0.16 to 1.01) and 24 months (OR, 0.54; 95% CI, 0.24 to 1.20). After adjustment for polycystic kidney disease, per-protocol ORs for PTDM (treatment versus controls) were 0.21 (95% CI, 0.07 to 0.62) at 12 months and 0.35 (95% CI, 0.14 to 0.87) at 24 months. Significantly more hypoglycemic events (mostly asymptomatic or mildly symptomatic) occurred in the treatment group versus the control group. Within the treatment group, nonadherence to the insulin initiation protocol was associated with significantly higher odds for PTDM at months 12 and 24.

conclusionsAt low overt PTDM incidence, the primary end point in the intention-to-treat population did not differ significantly between treatment and control groups. In the per-protocol analysis, early basal insulin therapy resulted in significantly higher hypoglycemia rates but reduced odds for overt PTDM-a significant reduction after adjustment for baseline differences-suggesting the intervention merits further study.

Indexed as

AdultAgedBlood GlucoseDiabetes MellitusFemaleGlycated HemoglobinGuideline AdherenceHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsInsulin, IsophaneInsulin LisproIntention to Treat AnalysisKidney TransplantationMaleBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin, IsophaneInsulin Lisprocardiovascularclinical trialdiabetesdiabetes mellitushyperglycemiakidney transplantationorgan transplantrandomized controlled trialsrenal transplantation

Identifiers

PMID34330770
PMCPMC8455276
OpenAlexW3183633816

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.