Evidence map›Paper›PMID 27515804›Full record

Trial reportEndocrine2017

Effects of chronic administration of the phosphodiesterase inhibitor vardenafil on serum levels of adrenal and testicular steroids in men with type 2 diabetes mellitus.

Daniele Santi, Antonio Rm Granata, Elisa Pignatti, Tommaso Trenti, Laura Roli, Roberto Bozic, Stefano Zaza, Chiara Pacchioni, Vincenzo Rochira, Cesare Carani and 1 more

Open access · greenAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Endocrine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 34% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. 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

11 authors at 2 institutions in 1 country.

Daniele SantiUnit of Endocrinology, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy. santi.daniele@gmail.com.ORCID http://orcid.org/0000-0001-6607-7105
Antonio Rm GranataDepartment of Medicine, Endocrinology, Metabolism and Geriatrics, Azienda USL of Modena, Modena, Italy.
Elisa PignattiUnit of Endocrinology, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Tommaso TrentiDepartment of Laboratory Medicine and Pathological Anatomy, Azienda USL of Modena, Modena, Italy.
Laura RoliDepartment of Laboratory Medicine and Pathological Anatomy, Azienda USL of Modena, Modena, Italy.
Roberto BozicPerkinElmer, 20126, Milan, Italy.
Stefano ZazaSHIMADZU Italia, Milan, Italy.
Chiara PacchioniDiabetic Service, Azienda USL of Modena, Modena, Italy.
Vincenzo RochiraUnit of Endocrinology, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Cesare CaraniUnit of Endocrinology, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Manuela SimoniUnit of Endocrinology, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
University of Modena and Reggio Emilia · ITAzienda Unita' Sanitaria Locale Di Modena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To investigate whether long-term, chronic treatment with the phosphodiesterase-5 inhibitor vardenafil affects adrenal and testicular steroidogenesis in diabetic men, using liquid chromatography-tandem mass spectrometry. A longitudinal, prospective, investigator-started, randomized, placebo-controlled, double-blind, clinical-trial was carried out, enrolling 54 male patients affected by type 2 diabetes mellitus diagnosed within the last 5 years. In total, 26 and 28 patients were followed for 1 year and assigned to the study and placebo group, respectively. Progesterone, 17-hydroxyprogesterone, androstenedione, testosterone, dehydroepiandrosterone, dehydroepiandrosterone sulfate, corticosterone, 11-deoxycortisol and cortisol, were evaluated using liquid chromatography-tandem mass spectrometry. No differences were seen in sex testicular steroids between study and control group. As for the adrenal gland, steroids were considered according to the zona in which they are produced. No significant differences were seen in steroid produced in zona fasciculata. For the zona reticularis, dehydroepiandrosterone significantly decreased during treatment only in the study group (p = 0.007), with higher levels at visit 2 and 8 than other visits. The dehydroepiandrosterone sulfate/dehydroepiandrosterone ratio significantly increased during treatment only in the verum group. Considering the adrenal zona glomerulosa, corticosterone significantly changed among visits both in both groups (p < 0.001), with higher levels at visit 2 (p = 0.028), 8 (p = 0.003), and 10 (p = 0.044), i.e., in coincidence with the complete clinical and instrumental examination performed only at these visits according to the study protocol. Chronically administered vardenafil reduces dehydroepiandrosterone levels and increases dehydroepiandrosterone sulfate/dehydroepiandrosterone ratio as possible consequences of modulation of steroidogenic enzymes by tissue changes in cyclic adenosine monophosphate and cyclic guanosine monophosphate availability. A possibly stress-related increase in corticosterone is suggested for the first time.

Indexed as

17-alpha-HydroxyprogesteroneAndrogensAndrostenedioneChromatography, LiquidCorticosteroneDiabetes Mellitus, Type 2Double-Blind MethodHumansHydrocortisoneLongitudinal StudiesMaleMiddle AgedProgesteroneProspective StudiesTandem Mass SpectrometryTestosterone17-alpha-HydroxyprogesteroneAndrogensAndrostenedioneCorticosteroneHydrocortisoneProgesteroneTestosteroneVardenafil DihydrochlorideAdrenal steroidMass-spectrometryType 2 diabetes mellitusVardenafil

Identifiers

PMID27515804
OpenAlexW2509452582

What OpenQuestion holds

Textmetadata
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.