Evidence mapPaperPMID 39678192Full record

Trial reportFrontiers in endocrinology2024

Serum exocrine pancreas enzymes are biomarkers of immunotherapy response in new-onset type 1 diabetes.

Brittany Sorensen Bruggeman, Savanna Gornisiewicz, Rhonda Bacher, Kieran McGrail, Martha Campbell-Thompson, Clive Wasserfall, Laura M Jacobsen, Mark Atkinson, Michael J Haller, Desmond A Schatz

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in endocrinology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

10 authors.

Brittany Sorensen BruggemanDivision of Endocrinology, Department of Pediatrics, University of Florida, Gainesville, FL, United States.
Savanna GornisiewiczCollege of Medicine, University of Florida, Gainesville, FL, United States.
Rhonda BacherDepartment of Biostatistics, University of Florida, Gainesville, FL, United States.
Kieran McGrailDepartment of Pathology, Immunology, and Laboratory Medicine, University of Florida, Gainesville, FL, United States.
Martha Campbell-ThompsonDepartment of Pathology, Immunology, and Laboratory Medicine, University of Florida, Gainesville, FL, United States.
Clive WasserfallDepartment of Pathology, Immunology, and Laboratory Medicine, University of Florida, Gainesville, FL, United States.
Laura M JacobsenDivision of Endocrinology, Department of Pediatrics, University of Florida, Gainesville, FL, United States.
Mark AtkinsonDepartment of Pathology, Immunology, and Laboratory Medicine, University of Florida, Gainesville, FL, United States.
Michael J HallerDivision of Endocrinology, Department of Pediatrics, University of Florida, Gainesville, FL, United States.
Desmond A SchatzDivision of Endocrinology, Department of Pediatrics, University of Florida, Gainesville, FL, United States.

Funding

Project 3P01AI042288 · NIAID · UNIVERSITY OF FLORIDA · 1997 to 2025
$11.1M
Resolving single-cell analysis challenges via data-driven decision frameworks and novel statistical methodsR35GM146895 · UNIVERSITY OF FLORIDA · 2025 to 2025
$371k
Natural History and Mechanisms of Exocrine Pancreatic Dysfunction in Pre-Type 1 DiabetesK23DK131363 · NIDDK · UNIVERSITY OF FLORIDA · 2024 to 2025
$312k
NCATS NIH HHS UL1 TR000064NIAID NIH HHS P01 AI042288NIDDK NIH HHS K23 DK131363NIGMS NIH HHS R35 GM146895
6 · The paper itself

Abstract

Introduction: The immune-mediated destruction of insulin-producing β-cells characterizes type 1 diabetes. Nevertheless, exocrine pancreatic enzymes, including amylase, lipase, and trypsin, are also significantly reduced in type 1 diabetes. With an immunotherapy now approved to treat early-stage type 1 diabetes, biomarkers to delineate response to treatment are needed. No study has yet evaluated whether serum exocrine pancreatic enzymes could delineate immunotherapy responders and non-responders. Methods: In this novel study, we sought to identify longitudinal trends in the most commonly measured circulating exocrine enzymes before and after treatment with anti-thymocyte globulin (ATG) and pegylated granulocyte colony-stimulating factor (GCSF) in individuals with new-onset type 1 diabetes (n=34). We defined response to immunotherapy as participants with at least 60% of baseline area under the curve (AUC) C-peptide levels after a 2-hour mixed meal tolerance test (MMTT) at two years post-treatment. In the overall study (n=89), 42% of treated and 17% of placebo participants met this definition. Due to constraints of sample availability, we compared longitudinal serum amylase, lipase, and trypsin levels in a subset of responders to therapy (n=4-6), placebo "responders" (n=2), treated non-responders (n=16), and placebo non-responders (n=10). Results: There were no differences in amylase levels between groups at baseline or six months post-treatment. Baseline levels of lipase and trypsin tended to be lower in responders; however, these variations were not significant in this small study sample. Lipase and trypsin improved to 115% of baseline in responders to immunotherapy six months after treatment and declined to 80-90% of baseline in non-responders and placebo participants (p=0.03). This difference was not present before the six-month time point. Discussion: Our findings provide preliminary evidence that the exocrine pancreatic enzymes lipase and trypsin may be useful biomarkers of response to immunotherapy in type 1 diabetes. Further studies with larger numbers of participants are warranted.

Indexed as

AmylasesBiomarkersDiabetes Mellitus, Type 1ImmunotherapyLipaseTrypsinAdolescentAdultFemaleGranulocyte Colony-Stimulating FactorHumansMaleMiddle AgedPancreas, ExocrineTreatment OutcomeYoung AdultAmylasesBiomarkersGranulocyte Colony-Stimulating FactorLipaseTrypsinexocrine pancreasgranulocyte colony stimulating factorimmunotherapylipasepancreatic alpha-amylasethymoglobulintrypsintype 1 diabetes

Identifiers

PMID39678192
PMCPMC11637828

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.