Evidence map›Paper›PMID 31213865›Full record

ArticleDiabetes, metabolic syndrome and obesity : targets and therapy2019

Early effects of roflumilast on insulin sensitivity in adults with prediabetes and overweight/obesity involve age-associated fat mass loss - results of an exploratory study.

Ijeoma M Muo, Sandra D MacDonald, Ritu Madan, Sung-Jun Park, Ahmed M Gharib, Pedro E Martinez, Mary F Walter, Shanna B Yang, Justin A Rodante, Amber B Courville and 8 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes, metabolic syndrome and obesity : targets and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01862029 (An Exploratory Study to Evaluate the Effects of Roflumilast on Insulin Sensitivity and Metabolic Parameters in Prediabetic Overweight and Obese Individuals), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.1field-weighted citation impact, top 21% 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.

NCT01862029 phase1 / phase2completednot on this map

An Exploratory Study to Evaluate the Effects of Roflumilast on Insulin Sensitivity and Metabolic Parameters in Prediabetic Overweight and Obese Individuals

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2013 to 2017Enrolled24ConditionsObesityArmsRoflumilast
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 21 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Acute PDE4 Inhibition Induces a Transient Increase in Blood Glucose in Mice.International journal of molecular sciences · 2023
    Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Roflumilast Suppresses Adipogenic DifferentiationFrontiers in endocrinology · 2021
    Article
  11. Review
  12. 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

18 authors at 2 institutions in 1 country.

Ijeoma M MuoLaboratory of Obesity and Aging Research NHLBI, National Institutes of Health, Bethesda, MD 20892, USA, chungj@nhlbi.nih.gov, ijeoma.muo@nih.gov.
Sandra D MacDonaldNHLBI Pulmonary Branch, Laboratory of Chronic Airway Infections, National Institutes of Health, Bethesda, MD 20892, USA.
Ritu MadanDiabetes Endocrinology and Obesity Branch, NIDDK, National Institutes of Health, Bethesda, MD 20892, USA.
Sung-Jun ParkLaboratory of Obesity and Aging Research NHLBI, National Institutes of Health, Bethesda, MD 20892, USA, chungj@nhlbi.nih.gov, ijeoma.muo@nih.gov.
Ahmed M GharibBiomedical and Metabolic Imaging Branch NIDDK, National Institutes of Health, Bethesda, MD 20892, USA.
Pedro E MartinezSection on Behavioral Endocrinology, NIMH, National Institutes of Health, Bethesda, MD 20892, USA.
Mary F WalterDiabetes Endocrinology and Obesity Branch, NIDDK, National Institutes of Health, Bethesda, MD 20892, USA.
Shanna B YangClinical Center Nutrition Department, National Institutes of Health, Bethesda, MD 20892, USA.
Justin A RodanteLaboratory of Inflammation and Cardiometabolic Diseases, NHLBI, National Institutes of Health, Bethesda, MD 20892, USA.
Amber B CourvilleClinical Center Nutrition Department, National Institutes of Health, Bethesda, MD 20892, USA.
Peter J WalterMass Spectrometry Clinical Core, NIDDK, National Institutes of Health, Bethesda, MD 20892, USA.
Hongyi CaiMass Spectrometry Clinical Core, NIDDK, National Institutes of Health, Bethesda, MD 20892, USA.
Michael GlicksmanDiabetes Endocrinology and Obesity Branch, NIDDK, National Institutes of Health, Bethesda, MD 20892, USA.
Gioia M GuerrieriSection on Behavioral Endocrinology, NIMH, National Institutes of Health, Bethesda, MD 20892, USA.
Rivka R Ben-DorNIMH, National Institutes of Health, Bethesda, MD 20892, USA.
Ronald OuwerkerkBiomedical and Metabolic Imaging Branch NIDDK, National Institutes of Health, Bethesda, MD 20892, USA.
Stephanie MaoLaboratory of Obesity and Aging Research NHLBI, National Institutes of Health, Bethesda, MD 20892, USA, chungj@nhlbi.nih.gov, ijeoma.muo@nih.gov.
Jay H ChungLaboratory of Obesity and Aging Research NHLBI, National Institutes of Health, Bethesda, MD 20892, USA, chungj@nhlbi.nih.gov, ijeoma.muo@nih.gov.
National Institutes of Health · USNational Institutes of Health Clinical Center · US

Funding

Clinical Stable Isotope Research & SupportZICDK075039 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI WALTER, PETER · 2009 to 2025
$23.2M
Clinical Research and Assay SupportZICDK071006 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI WALTER, MARY · 2009 to 2025
$20.6M
An Exploratory Study to Evaluate the Effects of Roflumilast on Insulin Sensitivity and Metabolic Parameters in Prediabetic Overweight and Obese IndividualsZIAHL006198 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI CHUNG, JAY H · 2015 to 2019
$697k
6 · The paper itself

Abstract

purposeRoflumilast (Daliresp, Daxas) is a FDA-approved phosphodiesterase 4 (PDE4) inhibitor for the treatment of moderate-to-severe chronic obstructive pulmonary disease. In mice and in limited human studies, this oral medication can cause weight loss and improve insulin sensitivity. We set out to determine the mechanism of its effect on insulin sensitivity. PATIENTS AND

methodsEight adults with overweight/obesity and prediabetes received roflumilast for 6 weeks. Before and after roflumilast, subjects underwent tests of insulin sensitivity, mixed meal test, body composition, markers of inflammation, and mitochondria function. Dietary intake and physical activity were also assessed. Our primary outcome was the change in peripheral insulin sensitivity, as assessed by the hyper-insulinemic euglycemic clamp.

resultsThis study was underpowered for the primary outcome. Pre- and post-roflumilast mean peripheral insulin sensitivity were 48.7 and 70.0 mg/g fat free mass/minute, respectively, (

conclusionWe demonstrate, for the first time in humans, increasing percentage of fat mass loss from roflumilast with increasing age in adults with prediabetes and overweight/obesity. We also demonstrate novel associations among roflumilast-induced changes in incretin hormones, inflammatory markers, peripheral insulin sensitivity, and adiposity. We conclude that roflumilast's early effects on insulin sensitivity is indirect and likely mediated through roflumilast's prioritization of lipid over glucose handling. CLINICAL TRIALS REGISTRATION: NCT01862029.

Indexed as

agingdiabetesincretinsinflammationobesityphosphodiesterase 4

Identifiers

PMID31213865
PMCPMC6542328
OpenAlexW2945096555

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.