1. 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
- Author
-
Savio Sardinha, Vikas Moudgil, Karl Winckel, Sue Patterson, Terry Stedman, Dan Siskind, Shuichi Suetani, Carmen C.W. Lim, Dylan Flaws, John J. McGrath, Andrea Baker, Anthony W. Russell, Nadia Friend, and Steve Kisely
- Subjects
Male ,obesity ,endocrine system diseases ,Weight Gain ,law.invention ,Body Mass Index ,0302 clinical medicine ,Randomized controlled trial ,law ,Weight loss ,Metformin/pharmacology ,Diabetes Mellitus, Type 2/prevention & control ,Secondary Prevention ,Protocol ,030212 general & internal medicine ,Clozapine ,diabetes ,General Medicine ,Metformin ,3. Good health ,Treatment Outcome ,Mental Health ,Research Design ,Obesity/chemically induced ,Female ,medicine.symptom ,medicine.drug ,Antipsychotic Agents ,medicine.medical_specialty ,education ,Placebo ,metabolic syndrome ,Hypoglycemic Agents/pharmacology ,Schizophrenia/drug therapy ,03 medical and health sciences ,Double-Blind Method ,Diabetes mellitus ,Internal medicine ,Weight Loss ,medicine ,Humans ,Hypoglycemic Agents ,Body Weight/drug effects ,Weight Gain/drug effects ,business.industry ,Body Weight ,medicine.disease ,Clozapine/adverse effects ,schizophrenia ,Diabetes Mellitus, Type 2 ,Metabolic Syndrome/prevention & control ,Adjunctive treatment ,Antipsychotic Agents/adverse effects ,business ,Weight gain ,030217 neurology & neurosurgery - Abstract
IntroductionClozapine, 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 analysisA 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 disseminationEthics 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.Trial registration numberACTRN12617001547336; Pre-results.
- Published
- 2018
- Full Text
- View/download PDF