Evidence map›Paper›PMID 33752449›Full record

Trial reportDiabetes & vascular disease research

Testosterone and sex hormone-binding globulin in dysglycemic women at high cardiovascular risk: A report from the Outcome Reduction with an Initial Glargine Intervention trial.

Anne Wang, Hertzel C Gerstein, Shun Fu Lee, Sibylle Hess, Guillaume Paré, Lars Rydén, Linda G Mellbin

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

Trial report in Diabetes & vascular disease research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00069784 (A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus), which is not on this map. Cited by 6 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 3 pooled it
1.0field-weighted citation impact, top 24% 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.

NCT00069784 phase3completednot on this map

A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

TypeinterventionalSponsorSanofiRan2003 to 2011Enrolled12,537ConditionsDiabetes Mellitus, Non-Insulin-DependentArmsinsulin glargine (HOE901), omega-3 polyunsaturated fatty acids (PUFA), placebo, reusable pen device for insulin injection
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 3 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. A review of the role of testosterone in the care of the critically ill patient.The Southern African journal of critical care : the official journal of the Critical Care Society · 2024
    Review
  6. 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

7 authors at 4 institutions in 3 countries.

Anne WangDepartment of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0002-4047-7730
Hertzel C GersteinPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
Shun Fu LeePopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
Sibylle HessR&D, Translational Medicine & Early Development, Biomarkers & Clinical Bioanalyses, Sanofi Aventis Deutschland GmbH, Frankfurt, Germany.
Guillaume ParéPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
Lars RydénDepartment of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Linda G MellbinDepartment of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Population Health Research Institute · CAKarolinska University Hospital · SEKarolinska Institutet · SESanofi (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTotal and free testosterone and sex hormone-binding globulin may affect cardiovascular prognosis in women. The objective was to study the association between sex hormones and prognosis in women with dysglycemia and high cardiovascular risk.

methodsThis epidemiological report included dysglycemic women from the Outcome Reduction with an Initial Glargine Intervention trial (

resultsPatients (73% post-menopausal) were followed for a median of 6.1 years during which 377 cardiovascular events and 389 deaths occurred. In Cox analyses, total and free testosterone were not associated with any outcomes, but sex hormone-binding globulin was related to all-cause mortality in age adjusted (HR 1.15; 95% CI 1.06-1.24;

conclusionsIncreasing levels of baseline sex hormone-binding globulin were associated with an increased risk of all-cause mortality in dysglycemic women at high cardiovascular risk.

trial registrationClinicalTrials.gov no. NCT00069784.

Indexed as

AgedBiomarkersBlood GlucoseCause of DeathDiabetes Mellitus, Type 2FemaleHeart Disease Risk FactorsHumansHypoglycemic AgentsInsulin GlargineMiddle AgedPrediabetic StateProspective StudiesRisk AssessmentSex Hormone-Binding GlobulinTestosteroneBiomarkersBlood GlucoseHypoglycemic AgentsInsulin GlargineSex Hormone-Binding GlobulinSHBG protein, humanTestosteroneCardiovasculardiabetesprognosissex hormone-binding globulintestosteronewomen

Identifiers

PMID33752449
PMCPMC8481727
OpenAlexW3137701664

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.