Evidence map›Paper›PMID 39014446›Full record

Observational studyCardiovascular diabetology2024

BMI variability and cardiovascular outcomes within clinical trial and real-world environments in type 2 diabetes: an IMI2 SOPHIA study.

Robert J Massey, Yu Chen, Marina Panova-Noeva, Michaela Mattheus, Moneeza K Siddiqui, Nanette C Schloot, Antonio Ceriello, Ewan R Pearson, Adem Y Dawed

Abstract readComparative StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Cardiovascular diabetology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

  1. Article
  2. Article
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  5. 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

9 authors.

Robert J MasseyDivision of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, DD1 9SY, UK.
Yu ChenLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Marina Panova-NoevaTranslational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Michaela MattheusTranslational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Moneeza K SiddiquiDivision of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, DD1 9SY, UK.
Nanette C SchlootLilly Deutschland GmbH, Bad Homburg, Germany.
Antonio CerielloIRCCS MultiMedica, Via Milanese 300, 20099, Sesto San Giovanni, MI, Italy.
Ewan R PearsonDivision of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, DD1 9SY, UK.
Adem Y DawedDivision of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, DD1 9SY, UK. aydawed@dundee.ac.uk.

Funding

Innovative Medicines Initiative 2 Joint Undertaking 875534
6 · The paper itself

Abstract

backgroundBMI variability has been associated with increased cardiovascular disease risk in individuals with type 2 diabetes, however comparison between clinical studies and real-world observational evidence has been lacking. Furthermore, it is not known whether BMI variability has an effect independent of HbA1c variability.

methodsWe investigated the association between BMI variability and 3P-MACE risk in the Harmony Outcomes trial (n = 9198), and further analysed placebo arms of REWIND (n = 4440) and EMPA-REG OUTCOME (n = 2333) trials, followed by real-world data from the Tayside Bioresource (n = 6980) using Cox regression modelling. BMI variability was determined using average successive variability (ASV), with first major adverse cardiovascular event of non-fatal stroke, non-fatal myocardial infarction, and cardiovascular death (3P-MACE) as the primary outcome.

resultsAfter adjusting for cardiovascular risk factors, a + 1 SD increase in BMI variability was associated with increased 3P-MACE risk in Harmony Outcomes (HR 1.12, 95% CI 1.08-1.17, P < 0.001). The most variable quartile of participants experienced an 87% higher risk of 3P-MACE (P < 0.001) relative to the least variable. Similar associations were found in REWIND and Tayside Bioresource. Further analyses in the EMPA-REG OUTCOME trial did not replicate this association. BMI variability's impact on 3P-MACE risk was independent of HbA1c variability.

conclusionsIn individuals with type 2 diabetes, increased BMI variability was found to be an independent risk factor for 3P-MACE across cardiovascular outcome trials and real-world datasets. Future research should attempt to establish a causal relationship between BMI variability and cardiovascular outcomes.

Indexed as

BiomarkersBody Mass IndexCardiovascular DiseasesDiabetes Mellitus, Type 2Glycated HemoglobinHeart Disease Risk FactorsAgedBlood GlucoseFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicRisk AssessmentRisk FactorsSodium-Glucose Transporter 2 InhibitorsBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanSodium-Glucose Transporter 2 Inhibitors3P-MACE riskBMI variabilityCardiovascular diseaseDiabetes managementHbA1c variabilityHealth outcomesType 2 diabetes

Identifiers

PMID39014446
PMCPMC11253469

What Socratic holds

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LicenceCC BY
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Registered trials

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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.