Olanzapine for young PEople with aNorexia nervosa (OPEN): A protocol for an open-label feasibility study.

INTRODUCTION: Antipsychotics are routinely prescribed off-label for anorexia nervosa (AN) despite limited evidence. This article presents a protocol of a study aiming to assess the feasibility of a future definitive trial on olanzapine in young people with AN. METHODS AND ANALYSIS: In an open-label, one-armed feasibility study, 55 patients with AN or atypical AN, aged 12-24, receiving outpatient, inpatient or day-care treatment who are considered for olanzapine treatment will be recruited from NHS sites based in England. Assessments will be conducted at screening, baseline and at 8-, 16 weeks, 6- and 12 months. Primary feasibility parameters will be proportions of patients who agree to take olanzapine and who adhere to treatment and complete study assessments. Qualitative methods will be used to explore acceptability of the intervention and study design. Secondary feasibility parameters will be changes in body mass index, psychopathology, side effects, health-related quality of life, carer burden and proportion of participants who would enrol in a future randomised controlled trial. The study is funded by the National Institute for Health Research via Health Technology Assessment programme. DISCUSSION: Olanzapine for young PEople with aNorexia nervosa will inform a future randomised controlled trial on the efficacy and safety of prescribing olanzapine in young people with AN.

Assessment of complex treatment influence on systemic inflammation in overweight type 2 diabetes patients.

OBJECTIVE: Introduction: Long-term systemic inflammation may cause type 2 diabetes. Medications used to treat type 2 diabetes don't target inflammation therefore it's necessary to study how hypoglycemics can improve patient prognosis through modification of systemic inflammation. The aim: Our goal was to assess influence of liraglutide in complex therapy on proinflammatory cytokine levels in overweight patients with type 2 diabetes and compare it with metformin. PATIENTS AND METHODS: Meterials and methods: The study included 80 overweight patients with type 2 diabetes. We studied clinical parameters as well as antropometric: height, weight, BMI, abdomen circumference; hsCRP, proinflammatory cytokine (TNF-α, IL-1ß, IL-6) levels. Patients were treated according to an individualized treatment plan which included eating habit modification and dosed physical exercise. First and second groups were comparison groups. Patients in the first group received metformin as primary treatment up to 2500 mg/day (n=20). Patients in the second group received liraglutide up to 1.8 mg/day (n=30). Patients in the third (main) group received a combination of metformin (up to 2500 mg/day) and liraglutide up to 1.8 mg/day (n=30). RESULTS: Results and conclusions: Main group achieved a decrease in BMI from 28,48±2,1 kg/m2 to 23,9±1,8 kg/m2 (р<0,05), whereas such decrease in the liraglutide monotherapy group was from 28,59±2,5 kg/m2 to 25,87±2,3 kg/m2 (р<0,05) and from 28,65±3,2 kg/m2 to 27,46±2,8 kg/m2 (р>0,05) in the metformin monotherapy group. Liraglutide was more efficient in lowering inflammatory cytokine concentrations with TNF-α and IL-6 being more sensitive to its effects. Main group saw a decrease in TNF-α levels from 10,14±0,6 to 7,49±0,33 pg/ml (<0,001) and IL-6 levels from 11,12±0,7 to 7,84±0,62 pg/ml (<0,001).