Evidence map›Paper›PMID 24586256›Full record

Trial reportPloS one2014

The effect of a diiodothyronine mimetic on insulin sensitivity in male cardiometabolic patients: a double-blind randomized controlled trial.

Fleur van der Valk, Carlijne Hassing, Maartje Visser, Purav Thakkar, Anookh Mohanan, Kaushal Pathak, Chaitanya Dutt, Vijay Chauthaiwale, Mariette Ackermans, Aart Nederveen and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01408667 (A Phase 2A, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety and Efficacy of TRC150094 in Increasing Insulin Sensitivity in Male Patients With Increased Cardiometabolic Risk), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT01408667 phase1 / phase2completednot on this map

A Phase 2A, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety and Efficacy of TRC150094 in Increasing Insulin Sensitivity in Male Patients With Increased Cardiometabolic Risk

TypeinterventionalSponsorTorrent Pharmaceuticals LimitedRan2011Enrolled40ConditionsMetabolic Cardiovascular SyndromeArmsTRC150094, Placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 33 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Thyroid Hormone Analogues: An Update.Thyroid : official journal of the American Thyroid Association · 2020
    Review
  12. The role of thyroid hormone in metabolism and metabolic syndrome.Therapeutic advances in endocrinology and metabolism · 2020
    Review
  13. Article
  14. Novel thyroid hormones.Endocrine · 2019
    Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. 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

13 authors at 2 institutions in 2 countries.

Fleur van der ValkDepartment of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.
Carlijne HassingDepartment of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.
Maartje VisserDepartment of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.
Purav ThakkarClinical Research Department, Torrent Pharmaceuticals Limited, Village-Bhat, Dist. Gandhinagar, India.
Anookh MohananClinical Research Department, Torrent Pharmaceuticals Limited, Village-Bhat, Dist. Gandhinagar, India.
Kaushal PathakClinical Research Department, Torrent Pharmaceuticals Limited, Village-Bhat, Dist. Gandhinagar, India.
Chaitanya DuttClinical Research Department, Torrent Pharmaceuticals Limited, Village-Bhat, Dist. Gandhinagar, India.
Vijay ChauthaiwaleClinical Research Department, Torrent Pharmaceuticals Limited, Village-Bhat, Dist. Gandhinagar, India.
Mariette AckermansDepartment of Clinical Chemistry, Laboratory of Endocrinology, Academic Medical Center, Amsterdam, the Netherlands.
Aart NederveenDepartment of Radiology, Academic Medical Center, Amsterdam, the Netherlands.
Mireille SerlieDepartment of Endocrinology, Academic Medical Center, Amsterdam, the Netherlands.
Max NieuwdorpDepartment of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.
Erik StroesDepartment of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.
Academic Medical Center · NLTorrent Pharma (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsObesity and its associated cardiometabolic co-morbidities are increasing worldwide. Since thyroid hormone mimetics are capable of uncoupling the beneficial metabolic effects of thyroid hormones from their deleterious effects on heart, bone and muscle, this class of drug is considered as adjacent therapeutics to weight-lowering strategies. This study investigated the safety and efficacy of TRC150094, a thyroid hormone mimetic. MATERIALS AND

methodsThis 4-week, randomized, placebo-controlled, double-blind trial was conducted in India and The Netherlands. Forty subjects were randomized at a 1:1 ratio to receive either TRC150094 dosed at 50 mg or placebo once daily for 4 weeks. Hyperinsulinemic euglycemic clamp and (1)H-Magnetic Resonance Spectroscopy (MRS) were performed before and after treatment.

resultsAt baseline, subjects were characterized by markedly impaired hepatic and peripheral insulin sensitivity. TRC150094 dosed 50 mg once daily was safe and well tolerated. Hepatic nor peripheral insulin sensitivity improved after TRC150094 treatment, expressed as the suppression of Endogenous Glucose Production from 59.5 to 62.1%; p = 0.477, and the rate of glucose disappearance from 28.8 to 26.4 µmol kg(-1)min(-1), p = 0.185. TRC150094 administration did not result in differences in fasting plasma free fatty acids from 0.51 to 0.51 mmol/L, p = 0.887 or in insulin-mediated suppression of lipolysis from 57 to 54%, p = 0.102. Also, intrahepatic triglyceride content was unaltered.

conclusionCollectively, these data show that, in contrast to the potent metabolic effects in experimental models, TRC150094 at a dose of 50 mg daily does not improve the metabolic homeostasis in subjects at an increased cardiometabolic risk. Further studies are needed to evaluate whether TRC150094 has beneficial effects in patients with more severe metabolic derangement, such as overt diabetes mellitus and hypertriglyceridemia.

trial registrationclinicaltrials.gov NCT01408667.

Indexed as

AdultDiiodothyroninesGlucose Clamp TechniqueHumansIndiaInsulin ResistanceMagnetic Resonance SpectroscopyMaleMetabolic SyndromeMiddle AgedNetherlandsStatistics, NonparametricThyroninesDiiodothyroninesThyroninesTRC150094

Identifiers

PMID24586256
PMCPMC3931609
OpenAlexW2037677271

What OpenQuestion holds

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LicenceCC BY
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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.