Evidence map›Paper›PMID 40583128›Full record

Trial reportJournal of clinical pharmacology2025

Intranasal Naloxone During Recurrent Exercise in Individuals with Type-1 Diabetes Mellitus: Evaluation of the Clinical Predictors of Pharmacokinetics and Exposure-Response.

Omar N Al Yacoub, Shen Cheng, Mohamed S Fayed, James Fisher, Jillian Brooks, Elizabeth Seaquist, Anjali Kumar, Amir Moheet, Lynn Eberly, Lisa D Coles

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Omar N Al YacoubDepartment of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.ORCID 0000-0002-2069-8472
Shen ChengDepartment of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.ORCID 0000-0002-7493-4784
Mohamed S FayedDepartment of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
James FisherDepartment of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
Jillian BrooksDepartment of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
Elizabeth SeaquistDivision of Diabetes, Endocrinology and Metabolism, Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
Anjali KumarDivision of Diabetes, Endocrinology and Metabolism, Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
Amir MoheetDivision of Diabetes, Endocrinology and Metabolism, Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
Lynn EberlyDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
Lisa D ColesDepartment of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.

Funding

Breakthrough T1D 3-SRA-2017-483-S-B NCE
6 · The paper itself

Abstract

Impaired awareness of hypoglycemia (IAH) impacts 25%-30% of individuals with type 1 diabetes mellitus (T1D), potentially leading to severe outcomes due to reduced symptom perception. Naloxone, a mu-opioid receptor antagonist, shows promise as a preventive measure against IAH. This study explored intranasal (IN) naloxone as a potential therapy to preserve counterregulatory and symptom responses to hypoglycemia following exercise in T1D patients. Participants included adults with T1D for 2-20 years. The study aimed to develop a population pharmacokinetic (PopPK) model of IN naloxone and assess exposure-response relationships. The study was conducted as a single-center, single-blinded, placebo-controlled crossover study. It involved collecting blood samples at 12 intervals before, during, and after exercise. Plasma naloxone concentrations were analyzed using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Utilizing nonlinear mixed effects modeling, the PopPK model simulated individual naloxone maximum concentrations (C

Indexed as

Diabetes Mellitus, Type 1ExerciseNaloxoneNarcotic AntagonistsAdministration, IntranasalAdolescentAdultArea Under CurveCross-Over StudiesFemaleHumansHypoglycemiaMaleMiddle AgedModels, BiologicalSingle-Blind MethodNaloxoneNarcotic Antagonistsexposure–responsehypoglycemianaloxonepharmacokineticsPopPKtype 1 diabetes mellitus

Identifiers

PMID40583128
PMCPMC12555105

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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.