Evidence map›Paper›PMID 28886024›Full record

Trial reportPloS one2017

Clomiphene citrate effect in obese men with low serum testosterone treated with metformin due to dysmetabolic disorders: A randomized, double-blind, placebo-controlled study.

Carla Pelusi, Vito Angelo Giagulli, Margherita Baccini, Flaminia Fanelli, Marco Mezzullo, Alessia Fazzini, Nicola Bianchi, Matteo Domenico Carbone, Giovanni De Pergola, Marianna Mastroroberto and 2 more

Open access · goldFull text readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  7. Review
  8. Review
  9. The role of the androgen receptor in the pathogenesis of obesity and its utility as a target for obesity treatments.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2022
    Review
  10. Article
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  17. Review
  18. The role of clomiphene citrate in late onset male hypogonadism.International braz j urol : official journal of the Brazilian Society of Urology
    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

12 authors at 3 institutions in 1 country.

Carla PelusiDivision of Endocrinology and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences, Alma Mater Studiorum, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.ORCID http://orcid.org/0000-0002-6390-2146
Vito Angelo GiagulliOutpatients Clinic of Endocrinology and Metabolic Disease, Conversano Hospital, Bari, Italy.
Margherita BacciniDivision of Endocrinology and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences, Alma Mater Studiorum, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.
Flaminia FanelliDivision of Endocrinology and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences, Alma Mater Studiorum, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.
Marco MezzulloDivision of Endocrinology and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences, Alma Mater Studiorum, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.
Alessia FazziniDivision of Endocrinology and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences, Alma Mater Studiorum, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.
Nicola BianchiDivision of Endocrinology and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences, Alma Mater Studiorum, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.
Matteo Domenico CarboneInstitute of Clinical and Hormonal Research, Foggia, Italy.
Giovanni De PergolaNutrition Outpatient Clinic, Clinical Oncology Unit, University of Bari, Bari, Italy.
Marianna MastrorobertoDivision of Endocrinology and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences, Alma Mater Studiorum, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.
Antonio Maria Morselli LabateDivision of Endocrinology and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences, Alma Mater Studiorum, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.
Renato PasqualiDivision of Endocrinology and Center for Applied Biomedical Research, Department of Medical & Surgical Sciences, Alma Mater Studiorum, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.
University of Bologna · ITUniversity of Bari Aldo Moro · ITUniversity of Foggia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextLow testosterone (T) levels are often found in obese men with impaired glucose tolerance (IGT) and overt type 2 diabetes (T2DM); however, the mechanisms underlying this condition and its correct therapy are still under debate.

objectiveTo evaluate the effectiveness of clomiphene citrate (CC) in increasing endogenous T levels in obese men with low serum T and with IGT or T2DM treated with metformin (MET).

designCross-over, randomized, double-blind, placebo-controlled study.

methods24 obese men, aged 47.3 ±. 6.3 (range 35-55 years), with low T level (≤3 ng/mL) and naïve diagnosis of IGT or T2DM were included. Subjects were randomized to CC 25 mg/day or placebo (Plac) with MET 2 g/day for 3 months. After a 6-week wash-out period, subjects were moved to the alternative arm for additional 3 months. Clinical evaluation and blood exams performed prior to and at the end of treatment.

resultsOf 24 randomized, 21 were evaluable, classified as IGT (n = 11) or T2DM (n = 10). Compared to baseline levels, T levels increased significantly after 3 months of CC treatment (3.03±0.80 to 5.99±1.67 ng/mL P<0.001) but not after the Plac treatment (2.87±0.78 to 3.09±0.84 ng/mL P<0.001 between the treatments). T changes were similar in IGT and T2DM subjects. Gonadotropins as well raised significantly after CC treatment (LH 3.83±1.45 to 8.53±6.40 mU/mL; FSH 4.84±1.67 to 10.15±5.08 mU/mL P<0.001 respectively), whereas no changes for LH (3.51±1.59 to 3.63±1.39 mU/mL) but a smooth increased for FSH (4.61±2.49 to 5.39±2.65 mU/mL; P = 0.004) were shown after Plac treatment (LH P = 0.001 and FSH P = 0.002 between treatments). Furthermore, fasting glucose (106.8±23.2 to 101.1±25.7 mg/dL; P = 0.004), insulin (19.3±12.1 to 15.6±10.1 μU/mL; P = 0.010) and HOMA-IR (4.94±2.89 to 3.69±2.12; P = 0.001) decreased significantly during the CC treatment period, whereas no significant changes were observed in any of these parameters in the Plac treatment.

conclusionsA low dose of CC therapy was able to significantly increase serum T levels in all participants with mild modifications of clinical and metabolic parameters.

trial registrationEudraCT 2011-000439-10.

Indexed as

AdultBiomarkersBody Weights and MeasuresClomipheneEnergy MetabolismHormonesHumansHypoglycemic AgentsMaleMetforminMiddle AgedObesitySelective Estrogen Receptor ModulatorsTestosteroneTreatment OutcomeBiomarkersClomipheneHormonesHypoglycemic AgentsMetforminSelective Estrogen Receptor ModulatorsTestosterone

Identifiers

PMID28886024
PMCPMC5590732
OpenAlexW2751936319

What OpenQuestion holds

Textfull text, public
LicenceCC BY
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.