Evidence map›Paper›PMID 36443174›Full record

Trial reportPancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.]2023

A randomized controlled pilot trial of etanercept and alpha-1 antitrypsin to improve autologous islet engraftment.

Tasneem R Abdel-Karim, James S Hodges, Timothy L Pruett, Karthik V Ramanathan, Bernhard J Hering, Ty B Dunn, Varvara A Kirchner, Gregory J Beilman, Melena D Bellin

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.], 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.5field-weighted citation impact, top 17% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  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

9 authors at 1 institution in 1 country.

Tasneem R Abdel-KarimDepartment of Pediatrics, University of Minnesota, Minneapolis, MN, USA.
James S HodgesDepartment of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
Timothy L PruettDepartment of Surgery, University of Minnesota, Minneapolis, MN, USA.
Karthik V RamanathanDepartment of Surgery, University of Minnesota, Minneapolis, MN, USA.
Bernhard J HeringDepartment of Surgery, University of Minnesota, Minneapolis, MN, USA.
Ty B DunnDepartment of Surgery, University of Minnesota, Minneapolis, MN, USA; Department of Surgery, University of Pennsylvania, Philadelphia, PA, USA.
Varvara A KirchnerDepartment of Surgery, University of Minnesota, Minneapolis, MN, USA; Department of Surgery, Stanford University, Palo Alto, CA, USA.
Gregory J BeilmanDepartment of Surgery, University of Minnesota, Minneapolis, MN, USA.
Melena D BellinDepartment of Pediatrics, University of Minnesota, Minneapolis, MN, USA; Department of Surgery, University of Minnesota, Minneapolis, MN, USA. Electronic address: bell0130@umn.edu.
University of Minnesota · US

Funding

University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR002494 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R, WEISDORF, DANIEL J · 2018 to 2022
$34.9M
Pre-Faculty Research Training in Pediatric EndocrinologyT32DK065519 · NIDDK · UNIVERSITY OF MINNESOTA TWIN CITIES · PI BELLIN, MELENA D. · 2004 to 2024
$3.6M
Anti-inflammatory therapy to improve outcomes in patients with chronic pancreatitis undergoing total pancreatectomy with islet autotransplant (TPIAT)R01DK109914 · NIDDK · UNIVERSITY OF MINNESOTA · PI BELLIN, MELENA D. · 2016 to 2020
$2.6M
NCATS NIH HHS UL1 TR002494NIDDK NIH HHS R01 DK109914NIDDK NIH HHS T32 DK065519
6 · The paper itself

Abstract

backgroundIn total pancreatectomy with islet auto-transplantation, successful diabetes outcomes are limited by islet loss from the instant blood mediated inflammatory response. We hypothesized that blockade of the inflammatory response with either etanercept or alpha-1-antitrypsin would improve islet function and insulin independence.

methodsWe randomized 43 participants to receive A1AT (90 mg/kg x 6 doses, n = 13), or etanercept (50 mg then 25 mg x 5 doses, n = 14), or standard care (n = 16), aiming to reduce detrimental effects of innate inflammation on early islet survival. Islet graft function was assessed using mixed meal tolerance testing, intravenous glucose tolerance testing, glucose-potentiated arginine-induced insulin secretion studies, HbA1c, and insulin dose 3 months and 1 year post-TPIAT.

resultsWe observed the most robust acute insulin response (AIRglu) and acute C-peptide response to glucose (ACRglu) at 3 months after TPIAT in the etanercept-treated group (p ≤ 0.02), but no differences in other efficacy measures. The groups did not differ overall at 1 year but when adjusted by sex, there was a trend towards a sex-specific treatment effect in females (AIRglu p = 0.05, ACRglu p = 0.06), with insulin secretion measures highest in A1AT-treated females.

conclusionOur randomized trial supports a potential role for etanercept in optimizing early islet engraftment but it is unclear whether this benefit is sustained. Further studies are needed to evaluate possible sex-specific responses to either treatment. CLINICAL TRIAL NOTATION: This study was performed under an Investigational New Drug Application (IND #119828) from the Food and Drug Administration and was registered on clinicaltrials.gov (NCT#02713997).

Indexed as

Diabetes MellitusIslets of Langerhans TransplantationPancreatitis, ChronicEtanerceptFemaleGlucoseHumansInsulinMalePancreatectomyPilot ProjectsThymalfasinTransplantation, AutologousTreatment OutcomeEtanerceptGlucoseInsulinThymalfasinChronic pancreatitisCytokinesDiabetesIslet autotransplantationTPIAT

Identifiers

PMID36443174
PMCPMC9839597
OpenAlexW4310061105

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.