Evidence map›Paper›PMID 39516143›Full record

Trial reportJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2025

Exogenous insulin does not reduce protein catabolism in pre-diabetic cystic fibrosis patients: A randomized clinical trial.

Michele Schiavon, Claudio Cobelli, K Sreekumaran Nair, Katherine Klaus, Gianna Toffolo, Lin Zhang, Antoinette Moran

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. The endocrine complications of cystic fibrosis.Nature reviews. Endocrinology · 2026
    Review
  2. 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

7 authors.

Michele SchiavonDepartment of Information Engineering, University of Padova, Via Gradenigo 6b, 35131, Padova, Italy. Electronic address: michele.schiavon@dei.unipd.it.
Claudio CobelliDepartment of Woman and Child's Health, University of Padova, Via Giustiniani n 3, 35128, Padova, Italy. Electronic address: cobelli@dei.unipd.it.
K Sreekumaran NairMayo Clinic College of Medicine, Division of Endocrinology and Research, 200 1st St SW, 5-194 Joseph, Rochester MN 55905. Electronic address: Nair@mayo.edu.
Katherine KlausMayo Clinic College of Medicine, Division of Endocrinology and Research, 200 1st St SW, 5-194 Joseph, Rochester MN 55905. Electronic address: Klaus.Katherine@mayo.edu.
Gianna ToffoloDepartment of Information Engineering, University of Padova, Via Gradenigo 6b, 35131, Padova, Italy. Electronic address: giannamaria.toffolo@unipd.it.
Lin ZhangDivision of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, University Office Plaza, Suite 200, 2221 University Avenue SE, Minneapolis, MN 55414. Electronic address: zhan4800@umn.edu.
Antoinette MoranDepartment of Pediatrics, University of Minnesota, Academic Office Building, AOB-120, 2450 Riverside Ave, Minneapolis, Minnesota 55454. Electronic address: moran001@umn.edu.

Funding

Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
TECHNOLOGY NMR SPECTROSCOPYU24DK100469 · NIDDK · MAYO CLINIC ROCHESTER · PI NAIR, K SREEKUMARAN · 2013 to 2017
$9.0M
The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic CF PatientsR01DK101402 · NIDDK · UNIVERSITY OF MINNESOTA · PI MORAN, ANTOINETTE M. · 2015 to 2019
$3.5M
NCATS NIH HHS UL1 TR000114NCATS NIH HHS UL1 TR000135NIDDK NIH HHS R01 DK101402NIDDK NIH HHS U24 DK100469
6 · The paper itself

Abstract

backgroundCystic Fibrosis (CF) patients historically suffered from undernutrition, infection and inflammation. Insulin insufficiency-related protein catabolism further compromised health. We aimed to determine whether insulin improves protein catabolism in CF youth with abnormal glucose tolerance (AGT).

methodsThis double-masked, placebo-controlled trial in CF youth age 10-25 with AGT who were in their usual state of health used triple-tracer stable-isotope methodology to measure protein turnover during a baseline test meal and after four weeks of insulin/placebo treatment. Healthy controls were assessed once. CF patients were randomized 1:1:1 to once-daily long-acting insulin (0.25 U/kg/d), three-times daily rapid-acting insulin (0.5 U/15gr carbohydrate), or injectable placebo.

resultsThirty CF patients completed the study. There were no differences in any measure of protein turnover between insulin- and placebo-treated subjects, including endogenous protein breakdown (primary study endpoint). In contrast to earlier studies, protein turnover in the 37 CF patients who completed the baseline meal was normal compared to 20 healthy controls. Meal isotope appeared in plasma earlier in CF than controls, suggesting more rapid gut emptying. The study was interrupted by the pandemic; futility analysis led to study discontinuation before the planned remaining 15 CF patients were studied.

conclusionsRecent advances in CF have led to remarkable clinical improvements. In this study, CF youth with AGT had normal protein catabolism at baseline. Pre-meal or daily basal insulin therapy, while safe and well tolerated, did not significantly enhance protein turnover and does not appear to be necessary in clinically stable patients prior to development of CFRD.

Indexed as

Cystic FibrosisGlucose IntoleranceInsulinAdolescentAdultChildDouble-Blind MethodFemaleHumansHypoglycemic AgentsMaleYoung AdultHypoglycemic AgentsInsulinCFRDCystic fibrosisMeal absorptionProtein catabolismProtein turnover

Identifiers

PMID39516143
PMCPMC11788023

What OpenQuestion holds

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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 OpenQuestion graph.