Evidence map›Paper›PMID 21307076›Full record

Trial reportDiabetes2011

Evidence that nasal insulin induces immune tolerance to insulin in adults with autoimmune diabetes.

Spiros Fourlanos, Christine Perry, Shane A Gellert, Emanuela Martinuzzi, Roberto Mallone, Jeanne Butler, Peter G Colman, Leonard C Harrison

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 1 pooled it
12.0field-weighted citation impact, top 1% 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

61 citing papers in PubMed, 1 synthesis or guideline pooled it, 116 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Prevention of Type 1 Diabetes in Children: A Worthy Challenge?International journal of environmental research and public health · 2023
    Review
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  14. The thymus and the science of self.Seminars in immunopathology · 2021
    Review
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  19. Article
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1 more citing papers are in PubMed but not listed here.

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

8 authors at 4 institutions in 2 countries.

Spiros FourlanosAutoimmunity and Transplantation Division, Walter and Eliza Hall, Institute of Medical Research, Parkville, Victoria, Australia.
Christine Perry
Shane A Gellert
Emanuela Martinuzzi
Roberto Mallone
Jeanne Butler
Peter G Colman
Leonard C Harrison
The Royal Melbourne Hospital · AUWalter and Eliza Hall Institute of Medical Research · AUDélégation Paris 5 · FRFondation de l'Avenir · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveInsulin in pancreatic β-cells is a target of autoimmunity in type 1 diabetes. In the NOD mouse model of type 1 diabetes, oral or nasal administration of insulin induces immune tolerance to insulin and protects against autoimmune diabetes. Evidence for tolerance to mucosally administered insulin or other autoantigens is poorly documented in humans. Adults with recent-onset type 1 diabetes in whom the disease process is subacute afford an opportunity to determine whether mucosal insulin induces tolerance to insulin subsequently injected for treatment. RESEARCH DESIGN AND

methodsWe randomized 52 adults with recent-onset, noninsulin-requiring type 1 diabetes to nasal insulin or placebo for 12 months. Fasting blood glucose and serum C-peptide, glucagon-stimulated serum C-peptide, and serum antibodies to islet antigens were monitored three times monthly for 24 months. An enhanced ELISpot assay was used to measure the T-cell response to human proinsulin.

resultsβ-Cell function declined by 35% overall, and 23 of 52 participants (44%) progressed to insulin treatment. Metabolic parameters remained similar between nasal insulin and placebo groups, but the insulin antibody response to injected insulin was significantly blunted in a sustained manner in those who had received nasal insulin. In a small cohort, the interferon-γ response of blood T-cells to proinsulin was suppressed after nasal insulin.

conclusionsAlthough nasal insulin did not retard loss of residual β-cell function in adults with established type 1 diabetes, evidence that it induced immune tolerance to insulin provides a rationale for its application to prevent diabetes in at-risk individuals.

Indexed as

Administration, IntranasalAdultAgedBlood GlucoseC-PeptideDiabetes Mellitus, Type 1Double-Blind MethodFastingFemaleHumansHypoglycemic AgentsImmune ToleranceInsulinInsulin AntibodiesMaleMiddle AgedBlood GlucoseC-PeptideHypoglycemic AgentsInsulinInsulin AntibodiesPlacebos

Identifiers

PMID21307076
PMCPMC3064097
OpenAlexW2119784820

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.