Evidence map›Paper›PMID 27733180›Full record

Trial reportTrials2016

The effects of linagliptin on endothelial function and global arginine bioavailability ratio in coronary artery disease patients with early diabetes: study protocol for a randomized controlled trial.

Norbert J Tripolt, Felix Aberer, Regina Riedl, Barbara Hutz, Jasmin Url, Gudrun Dimsity, Andreas Meinitzer, Tatjana Stojakovic, Ronald Hödl, Marianne Brodmann and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02350478 (Effects of Linagliptin on Endothelial Function and Global Arginine Bioavailability Ratio in Coronary Artery Disease Patients With Early Diabetes), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 21% 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.

NCT02350478 phase4completednot on this map

Effects of Linagliptin on Endothelial Function and Global Arginine Bioavailability Ratio in Coronary Artery Disease Patients With Early Diabetes

TypeinterventionalSponsorMedical University of GrazRan2013 to 2017Enrolled49ConditionsType 2 Diabetes, Coronary Artery DiseaseArmsLinagliptin, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

12 authors at 3 institutions in 1 country.

Norbert J TripoltDepartment of Internal Medicine, Division of Endocrinology and Diabetology, Cardiovascular Diabetology Research Group, Medical University of Graz, Graz, Austria.
Felix AbererDepartment of Internal Medicine, Division of Endocrinology and Diabetology, Cardiovascular Diabetology Research Group, Medical University of Graz, Graz, Austria.
Regina RiedlMedical University of Graz, Institute for Medical Informatics, Statistics and Documentation, Graz, Austria.
Barbara HutzDepartment of Internal Medicine, Division of Endocrinology and Diabetology, Cardiovascular Diabetology Research Group, Medical University of Graz, Graz, Austria.
Jasmin UrlDepartment of Internal Medicine, Division of Endocrinology and Diabetology, Cardiovascular Diabetology Research Group, Medical University of Graz, Graz, Austria.
Gudrun DimsityDepartment of Internal Medicine, Division of Angiology, Medical University of Graz, Graz, Austria.
Andreas MeinitzerClinical Institute of Medical and Chemical Laboratory Diagnostics, Graz, Austria.
Tatjana StojakovicClinical Institute of Medical and Chemical Laboratory Diagnostics, Graz, Austria.
Ronald HödlCenter for Cardiovascular Rehabilitation, St. Radegund, Austria.
Marianne BrodmannDepartment of Internal Medicine, Division of Angiology, Medical University of Graz, Graz, Austria.
Franz HafnerDepartment of Internal Medicine, Division of Angiology, Medical University of Graz, Graz, Austria.
Harald SourijDepartment of Internal Medicine, Division of Endocrinology and Diabetology, Cardiovascular Diabetology Research Group, Medical University of Graz, Graz, Austria. ha.sourij@medunigraz.at.
Medical University of Graz · ATLudwig Boltzmann Institute Applied Diagnostics · ATCenter For Biomarker Research In Medicine · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with type 2 diabetes (T2DM) are at increased risk for macrovascular events as well as for microvascular complications. There is evidence that in patients with coronary artery disease (CAD), about 35 % suffer from manifest T2DM. Early glucose-lowering intervention in subjects with T2DM has been demonstrated to be beneficial in terms of cardiovascular risk reduction. But thus far, no data are available regarding investigating the impact of linagliptin treatment in patients with early diabetes on cardiovascular endpoints or surrogate parameters. Therefore, the aim of this study is to investigate the effects of linagliptin in CAD patients with early T2DM on various cardiovascular surrogate measurements including mechanical and biochemical endothelial function assessments. METHODS/

designForty-two subjects with early diabetes and CAD are included in this investigator-driven, randomized, placebo-controlled, double-blind, phase IV, single-center study. Participants will be randomized to receive either linagliptin (5 mg) administered once daily per os or placebo for 12 weeks. Before and after the intervention, evaluation of endothelial function (flow-mediated dilatation and biochemical biomarkers) and a Meal Tolerance Test are performed. DISCUSSION: Cardiovascular surrogate parameters, such as endothelial function, are able to provide insights into the potential mechanisms of the cardiovascular effects of antihyperglycemic agents. Currently ongoing trials do not specifically focus on early diabetes as a target of intervention and we therefore believe that our study will contribute to a better understanding of the cardiovascular effects of dipeptidylpeptidase-4 (DPP-4) inhibitors in early diabetes.

trial registrationNCT02350478 . Registered 26 January 2015. Protocol date/version 24 October 2014/version 2.4 EudraCT number: 2013-000330-35.

Indexed as

AdultAgedAged, 80 and overArginineAustriaBiological AvailabilityBiomarkersBrachial ArteryClinical ProtocolsCoronary Artery DiseaseDiabetes Mellitus, Type 2Diabetic AngiopathiesDipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodEndothelium, VascularFemaleArginineBiomarkersDipeptidyl-Peptidase IV InhibitorsLinagliptinCoronary artery diseaseDPP-4 inhibitorEndothelial functionGlobal arginine bioavailability ratioLinagliptinType 2 diabetes mellitus

Identifiers

PMID27733180
PMCPMC5062940
OpenAlexW2530884289

What Socratic holds

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LicenceCC BY
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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 Socratic graph.