Evidence map›Paper›PMID 24130358›Full record

Trial reportDiabetes care2013

Targeting inflammation using salsalate in patients with type 2 diabetes: effects on flow-mediated dilation (TINSAL-FMD).

Allison B Goldfine, J Stewart Buck, Cyrus Desouza, Vivian Fonseca, Yii-Der Ida Chen, Steven E Shoelson, Kathleen A Jablonski, Mark A Creager, TINSAL-FMD (Targeting Inflammation Using Salsalate in Type 2 Diabetes–Flow-Mediated Dilation) Ancillary Study Team

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
5.3field-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

21 citing papers in PubMed, 51 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Targeting inflammation in atherosclerosis: overview, strategy and directions.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Review
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  7. Review
  8. Review
  9. Review
  10. Inflammation and insulin resistance: New targets encourage new thinking: Galectin-3 and LTBBioEssays : news and reviews in molecular, cellular and developmental biology · 2017
    Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
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  17. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Allison B GoldfineCorresponding author: Mark A. Creager, mcreager@partners.org.
J Stewart Buck
Cyrus Desouza
Vivian Fonseca
Yii-Der Ida Chen
Steven E Shoelson
Kathleen A Jablonski
Mark A Creager
TINSAL-FMD (Targeting Inflammation Using Salsalate in Type 2 Diabetes–Flow-Mediated Dilation) Ancillary Study Team
Brigham and Women's Hospital · USJoslin Diabetes Center · USCedars-Sinai Medical Center · USGeorge Washington University · USTulane University · USUniversity of Nebraska at Omaha · US

Funding

Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI Leigh Lamonica · 2012 to 2026
$69.1M
UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
Transgenic & Knock-out MouseP30DK063491 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Andrea L Hevener · 2003 to 2026
$40.4M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
Weight Loss, Inflammation, and Vascular RemodelingP50HL083813 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI WELTY, FRANCINE K · 2006 to 2015
$13.0M
Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using SalsalateU01DK074556 · NIDDK · JOSLIN DIABETES CENTER · PI SHOELSON, STEVEN E · 2006 to 2010
$7.8M
Targeting Inflammation to Improve Endothelial Function in Type 2 Diabetes: A SubsR01HL091750 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI CREAGER, MARK A · 2008 to 2010
$1.1M
NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1 TR000454NHLBI NIH HHS P50 HL083813NHLBI NIH HHS P50 HL83813NHLBI NIH HHS R01 HL091750NIDDK NIH HHS P30 DK063491NIDDK NIH HHS U01 DK074556NIDDK NIH HHS U01 DK74556NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

objectiveTo test whether inhibiting inflammation with salsalate improves endothelial function in patients with type 2 diabetes (T2D). RESEARCH DESIGN AND

methodsWe conducted an ancillary study to the National Institutes of Health-sponsored, multicenter, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of salsalate in targeting inflammation to improve glycemia in patients with T2D. Flow-mediated, endothelium-dependent dilation (FMD) and endothelium-independent, nitroglycerin-mediated dilation (NMD) of the brachial artery were assessed at baseline and 3 and 6 months following randomization to either salsalate 3.5 g/day or placebo. The primary end point was change in FMD at 6 months.

resultsA total of 88 participants were enrolled in the study, and data after randomization were available for 75. Patients in the treatment and control groups had similar ages (56 years), BMI (33 kg/m(2)), sex (64% male), ethnicity, current treatment, and baseline HbA1c (7.7% [61 mmol/mol]). In patients treated with salsalate versus placebo, HbA1c was reduced by 0.46% (5.0 mmol/mol; P < 0.001), fasting glucose by 16.1 mg/dL (P < 0.001), and white blood cell count by 430 cells/µL (P < 0.02). There was no difference in the mean change in either FMD (0.70% [95% CI -0.86 to 2.25%]; P = 0.38) or NMD (-0.59% [95% CI -2.70 to 1.51%]; P = 0.57) between the groups treated with salsalate and placebo at 6 months. Total and LDL cholesterol were 11 and 16 mg/dL higher, respectively, and urinary albumin was 2.0 µg/mg creatinine higher in the patients treated with salsalate compared with those treated with placebo (all P < 0.009).

conclusionsSalsalate does not change FMD in peripheral conduit arteries in patients with T2D despite lowering HbA1c. This finding suggests that salsalate does not have an effect on vascular inflammation, inflammation does not cause endothelial dysfunction in T2D, or confounding effects of salsalate mitigate favorable effects on endothelial function.

Indexed as

Administration, OralAdultAnti-Inflammatory Agents, Non-SteroidalBlood GlucoseBrachial ArteryDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationEndothelium, VascularFemaleFollow-Up StudiesHumansHypoglycemic AgentsInflammationMaleAnti-Inflammatory Agents, Non-SteroidalBlood GlucoseHypoglycemic AgentsSalicylatessalicylsalicylic acid

Identifiers

PMID24130358
PMCPMC3836144
OpenAlexW1988771872

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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 OpenQuestion graph.