Evidence mapPaperPMID 26864124Full record

Trial reportCardiovascular diabetology2016

LEADER 5: prevalence and cardiometabolic impact of obesity in cardiovascular high-risk patients with type 2 diabetes mellitus: baseline global data from the LEADER trial.

L Masmiquel, L A Leiter, J Vidal, S Bain, J Petrie, E Franek, I Raz, A Comlekci, S Jacob, L van Gaal and 4 more

Registry-linked trialOpen access · goldFull text readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cardiovascular diabetology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01179048. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
6.9field-weighted citation impact, top 3% 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.

NCT01179048 phase3completed

A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events

Ran2010Enrolled9,341Registered outcomes6Posted comparisons20ConditionsDiabetes, Diabetes Mellitus, Type 2Armsliraglutide, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Association between non-high-density lipoprotein cholesterol to high-density lipoprotein cholesterol ratio (NHHR) and cognitive impairment in middle-aged and elderly Chinese population.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Article
  4. Article
  5. Article
  6. Cardio-renal-metabolic disease in primary care setting.Diabetes/metabolism research and reviews · 2024
    Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. Observational
  13. Article
  14. Observational
  15. Article
  16. Article
  17. Article
  18. Association Between 25-Hydroxyvitamin D and Epicardial Adipose Tissue in Chinese Non-Obese Patients with Type 2 Diabetes.Medical science monitor : international medical journal of experimental and clinical research · 2017
    Article
  19. 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

14 authors at 10 institutions in 12 countries.

L MasmiquelEndocrinology and Nutrition Department, Hospital Son Llàtzer, University Institute of Health Science Research (IUNICS-IdISPa), Universitat de les Illes Balears, Palma, Majorca, Spain. lmasmiquel@gmail.com.
L A LeiterDivisions of Endocrinology and Metabolism, Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada. leiterl@smh.ca.
J VidalEndocrinology and Nutrition Department, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain. JOVIDAL@clinic.ub.es.
S BainInstitute of Life Science, Swansea University, Swansea, UK. S.C.Bain@swansea.ac.uk.
J PetrieInstitute of Cardiovascular and Medical Science, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. John.Petrie@glasgow.ac.uk.
E FranekMossakowski Medical Research Centre, Polish Academy of Sciences and Central Clinical Hospital MSW, Warsaw, Poland. Edward.Franek@cskmswia.pl.
I RazDiabetes Unit, Internal Medicine Division, Hadassah Hebrew University Hospital, Jerusalem, Israel. ntv502@netvision.net.il.
A ComlekciDepartment of Internal Medicine, Division of Endocrinology, Inciralti, Izmir, Turkey. comlekci@deu.edu.tr.
S JacobPraxis für Prävention und Therapie, Kardio Metabolischen Instituts, Villingen-Schwenningen, Germany. prof.dr.jacob@web.de.
L van GaalDepartment of Endocrinology, Diabetology, and Metabolism, Faculty of Medicine, Antwerp University Hospital, Edegem, Antwerp, Belgium. Luc.Van.Gaal@uza.be.
F M M BaeresNovo Nordisk, Copenhagen, Denmark. FMMB@novonordisk.com.
S P MarsoDivision of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX, USA. Steven.marso@utsouthwestern.edu.
M ErikssonDepartment of Endocrinology, Metabolism and Diabetes, Karolinska University Hospital, Stockholm, Sweden. Mats.Eriksson@ki.se.
LEADER investigators
Karolinska University Hospital · SENovo Nordisk (Denmark) · DKSt. Michael's Hospital · CASwansea University · GBAntwerp University Hospital · BECentral Clinical Hospital · PLHebrew University of Jerusalem · ILHospital Son Llatzer · ESIzmir University · TRMossakowski Medical Research Institute, Polish Academy of Sciences · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEpidemiological data on obesity are needed, particularly in patients with type 2 diabetes mellitus (T2DM) and high cardiovascular (CV) risk. We used the baseline data of liraglutide effect and action in diabetes: evaluation of CV outcome results-A long term Evaluation (LEADER) (a clinical trial to assess the CV safety of liraglutide) to investigate: (i) prevalence of overweight and obesity; (ii) relationship of the major cardiometabolic risk factors with anthropometric measures of adiposity [body mass index (BMI) and waist circumference (WC)]; and (iii) cardiometabolic treatment intensity in relation to BMI and WC.

methodsLEADER enrolled two distinct populations of high-risk patients with T2DM in 32 countries: (1) aged ≥50 years with prior CV disease; (2) aged ≥60 years with one or more CV risk factors. Associations of metabolic variables, demographic variables and treatment intensity with anthropometric measurements (BMI and WC) were explored using regression models (ClinicalTrials.gov identifier: NCT01179048).

resultsMean BMI was 32.5 ± 6.3 kg/m(2) and only 9.1 % had BMI <25 kg/m(2). The prevalence of healthy WC was also extremely low (6.4 % according to International Joint Interim Statement for the Harmonization of the Metabolic Syndrome criteria). Obesity was associated with being younger, female, previous smoker, Caucasian, American, with shorter diabetes duration, uncontrolled blood pressure (BP), antihypertensive agents, insulin plus oral antihyperglycaemic treatment, higher levels of triglycerides and lower levels of high-density lipoprotein cholesterol.

conclusionsOverweight and obesity are prevalent in high CV risk patients with T2DM. BMI and WC are related to the major cardiometabolic risk factors. Furthermore, treatment intensity, such as insulin, statins or oral antihypertensive drugs, is higher in those who are overweight or obese; while BP and lipid control in these patients are remarkably suboptimal. LEADER confers a unique opportunity to explore the longitudinal effect of weight on CV risk factors and hard endpoints.

Indexed as

AgedAged, 80 and overBody Mass IndexCardiovascular DiseasesDiabetes Mellitus, Type 2Double-Blind MethodFemaleHumansHypoglycemic AgentsLiraglutideMaleMetabolic SyndromeMiddle AgedObesityPrevalenceRisk AssessmentHypoglycemic AgentsLiraglutide

Identifiers

PMID26864124
PMCPMC4750199
OpenAlexW2279162094

What Socratic holds

Textfull text, public
LicenceCC BY
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.