Evidence map›Paper›PMID 38178557›Full record

Trial reportJournal of cachexia, sarcopenia and muscle2024

A randomized controlled pilot trial of anakinra and pioglitazone for protein metabolism in patients on maintenance haemodialysis.

Lale A Ertuglu, Serpil Muge Deger, Aseel Alsouqi, Adriana Hung, Jorge Gamboa, Cindy Mambungu, Feng Sha, Edward Siew, Naji N Abumrad, T Alp Ikizler

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

Trial report in Journal of cachexia, sarcopenia and muscle, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02278562 (Nutrition, Inflammation and Insulin Resistance in End-Stage Renal Disease), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.4field-weighted citation impact, top 19% 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.

NCT02278562 phase2completednot on this map

Nutrition, Inflammation and Insulin Resistance in End-Stage Renal Disease

TypeinterventionalSponsorVA Office of Research and DevelopmentRan2014 to 2017Enrolled33ConditionsESRDArmsanakinra, actos, placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
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

10 authors at 4 institutions in 2 countries.

Lale A ErtugluDepartment of Medicine, Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, TN, USA.
Serpil Muge DegerDepartment of Nephrology, Faculty of Medicine, Dokuz Eylul University, Izmir, Turkey.
Aseel AlsouqiDepartment of Medicine, Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, TN, USA.
Adriana HungDepartment of Medicine, Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, TN, USA.
Jorge GamboaDepartment of Medicine, Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, TN, USA.
Cindy MambunguDepartment of Medicine, Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, TN, USA.
Feng ShaDepartment of Medicine, Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, TN, USA.
Edward SiewDepartment of Medicine, Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, TN, USA.
Naji N AbumradDepartment of Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.
T Alp IkizlerDepartment of Medicine, Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, TN, USA.ORCID 0000-0002-5717-4218
Vanderbilt University Medical Center · USVA Tennessee Valley Healthcare System · USDokuz Eylül University · TRUniversity of Pittsburgh Medical Center · US

Funding

Role of Mitochondrial Dysfunction in the Response to Exercise in Patients with Advanced Kidney DiseaseR01DK125794 · NIDDK · VANDERBILT UNIVERSITY MEDICAL CENTER · PI GAMBOA, JORGE LUIS, IKIZLER, TALAT ALP · 2021 to 2025
$3.3M
NIDDK NIH HHS R01 DK125794
6 · The paper itself

Abstract

backgroundChronic inflammation and insulin resistance are highly prevalent in patients on maintenance haemodialysis (MHD) and are strongly associated with protein energy wasting. We conducted a pilot, randomized, placebo-controlled trial of recombinant human interleukin-1 receptor antagonist (IL-1ra) and pioglitazone to explore the safety, feasibility and efficacy for insulin-mediated protein metabolism in patients undergoing MHD.

methodsTwenty-four patients were randomized to receive IL-1ra, pioglitazone or placebo for 12 weeks. Changes in serum inflammatory markers and insulin-mediated protein synthesis, breakdown and net balance in the whole-body and skeletal muscle compartments were assessed using hyperinsulinaemic-hyperaminoacidemic clamp technique at baseline and Week 12.

resultsAmong 24 patients, median (interquartile range) age was 51 (40, 61), 79% were African American and 21% had diabetes mellitus. All patients initiated on intervention completed the study, and no serious adverse events were observed. There was a statistically significant decrease in serum high-sensitivity C-reactive protein in the pioglitazone group compared with placebo, but not in the IL-1ra group. No significant differences in the changes of whole-body or skeletal muscle protein synthesis, breakdown and net balance were found between the groups.

conclusionsIn this pilot study, there were no statistically significant effects of 12 weeks of IL-1ra or pioglitazone on protein metabolism in patients on MHD. CLINICALTRIALS: gov registration: NCT02278562.

Indexed as

Interleukin 1 Receptor Antagonist ProteinRenal DialysisBiomarkersHumansInsulinPilot ProjectsPioglitazoneBiomarkersInsulinInterleukin 1 Receptor Antagonist ProteinPioglitazoneinflammationinsulin resistancemaintenance haemodialysisprotein metabolism

Identifiers

PMID38178557
PMCPMC10834322
OpenAlexW4390609903

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.