Discussion The proposed core outcome set will provide clear guidance about what outcomes should be measured , as a minimum , in trials of interventions for people with coexisting type-2 diabetes and SMI , and improve future synthesis of trial evidence in this area .
Background People with diabetes and comorbid severe mental illness ( SMI ) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone .
There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities .
However , there is a lack of consensus about which outcomes are important for this comorbid population , with trials differing in their focus on physical and mental health .
A core outcome set , which includes outcomes across both conditions that are relevant to patients and other key stakeholders , is needed .
Placebo-Controlled Pilot Study of Ramelteon for Adiposity and Lipids in Patients With Schizophrenia
Objective : Few interventions have been successful to prevent or reverse the medical complications associated with antipsychotic agents in the schizophrenia population . In particular , no single agent can correct multiple metabolic abnormalities such as insulin resistance , hyperlipidemia , inflammation , obesity , and fat distribution . We now report a r and omized placebo-controlled pilot study to examine the effects of ramelteon on obesity and metabolic disturbances among subjects with schizophrenia . Methods : A double-blind , placebo-controlled , 8-week pilot trial was conducted , adding ramelteon 8 mg/d to stable out patients with schizophrenia .  Vital signs and anthropometric measurements , including height , weight , waist circumference , and body fat were assessed , and laboratory assays were tracked to monitor changes in metabolic markers . Results : Twenty-five subjects were r and omly assigned to treatment with study drug or placebo , and 20 subjects were included in the final analysis .  Ramelteon did not improve anthropometric measurements , glucose metabolism , and inflammatory markers . There was , however , a significant decrease in total cholesterol and ratio of cholesterol to high-density lipoprotein in the ramelteon group . Although the st and ard anthropometric measures did not show significant change , the dual-energy x-ray absorptiometry scan showed a trend toward reduction in fat in the abdominal and trunk areas with a moderate effect size . Conclusions : Although ramelteon decreased cholesterol , treatment may have to be longer than 8 weeks and with a higher dose for maximal effect of ramelteon for body fat and lipid changes . Future studies are needed for patients with schizophrenia with a larger sample size to fully underst and ramelteon 's effects on abdominal adiposity and lipids
Discussion The proposed core outcome set will provide clear guidance about what outcomes should be measured , as a minimum , in trials of interventions for people with coexisting type-2 diabetes and SMI , and improve future synthesis of trial evidence in this area .
Background People with diabetes and comorbid severe mental illness ( SMI ) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone .
There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities .
However , there is a lack of consensus about which outcomes are important for this comorbid population , with trials differing in their focus on physical and mental health .
A core outcome set , which includes outcomes across both conditions that are relevant to patients and other key stakeholders , is needed .