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  • CoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine

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    Author(s)
    Siskind, Dan
    Friend, Nadia
    Russell, Anthony
    McGraths, John J
    Lim, Carmen
    Patterson, Sue
    Flaws, Dylan
    Stedman, Terry
    Moudgil, Vikas
    Sardinha, Savio
    Suetani, Shuichi
    Kisely, Steve
    Winckel, Karl
    Baker, Andrea
    Griffith University Author(s)
    Kisely, Steve R.
    Suetani, Shuichi
    Sardinha, Savio
    Year published
    2018
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    Abstract
    Introduction: Clozapine, while effective in treatment refractory schizophrenia, is associated with significant weight gain, heart disease and increased risk of type 2 diabetes mellitus (T2DM). Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation. Methods and analysis: A 24-week double-blind placebo-controlled trial of concomitant prescription of metformin at clozapine commencement. Eighty-six people being commenced on ...
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    Introduction: Clozapine, while effective in treatment refractory schizophrenia, is associated with significant weight gain, heart disease and increased risk of type 2 diabetes mellitus (T2DM). Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation. Methods and analysis: A 24-week double-blind placebo-controlled trial of concomitant prescription of metformin at clozapine commencement. Eighty-six people being commenced on clozapine will be randomised to placebo or metformin (variable dose, up to 2 g/day). The primary outcome is comparative end point body weight, between the placebo and metformin groups. Secondary outcomes are comparative rates of conversion to T2DM, alteration of metabolic syndrome parameters, proportion gaining >5% body weight and changes in diet and appetite. We will additionally examine biomarkers associated with change in weight among trial participants. Ethics and dissemination: Ethics approval was granted by the Metro South Human Research Ethics Committee HREC/17/QPAH/538-SSA/17/QPAH/565. We plan to submit a manuscript of the results to a peer-reviewed journal, and present results at conferences, consumer forums and hospital grand rounds.
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    Journal Title
    BMJ OPEN
    Volume
    8
    Issue
    3
    DOI
    https://doi.org/10.1136/bmjopen-2017-021000
    Copyright Statement
    © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
    Subject
    Clinical sciences
    Clinical sciences not elsewhere classified
    Health services and systems
    Public health
    Other health sciences
    Publication URI
    http://hdl.handle.net/10072/383621
    Collection
    • Journal articles

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