Smetanina 2015.

Methods	Type of trial: interventional Allocation: randomised Intervention model: parallel assignment Masking: unclear Primary purpose: treatment
Participants	Condition: overweight and obesity in children and adolescents Enrolment: 145 Inclusion criteria: overweight (BMI SDS 1.0 to 2.0) or obese (BMI ≥ 2.0) (IOTF) children or adolescents Exclusion criteria: ‐
Interventions	Interventions: metformin combined with lifestyle changes metformin only Comparators: lifestyle changes only no treatment controls
Outcomes	Primary outcomes: BMI SDS waist circumference waist SDS adverse events lean mass Secondary outcomes: none given Other outcomes: none given
Study identifier	‐
Official title	‐
Stated purpose of study	"To assess the efficacy and safety of Metformin use in combination with lifestyle changes or alone for weight management in OW and OB children and adolescents"
Notes	Project supported by Research Council of Lithuania (grant Nr MIP‐039/2013) and Research Foundation of Lithuanian University of Health Sciences (grants 2012 and 2013) Results: reduction in BMI, waist circumference and waist circumference SDS adjusted by sex and puberty stages was significantly greater in the metformin + lifestyle changes group compared to the controls no treatment group. Change in BMI after 12 months' intervention: controls = +0.18 kg/m2, lifestyle changes only = +0.43 kg/m2, metformin only = ‐0.59 kg/m2, metformin + lifestyle changes = ‐1.07 kg/m2. Change in waist circumference after 12 months' intervention: controls = ‐1.8 cm, lifestyle changes only = ‐2.8 cm, metformin only = ‐2.3 cm, metformin + lifestyle changes = ‐4.5 cm. Change in waist circumference SDS after 12 months' intervention: controls = ‐0.38, lifestyle changes only = ‐0.58, metformin only = ‐0.49, metformin + lifestyle changes = ‐0.85. Initially, there were mild adverse effects with metformin (nausea, diarrhoea) in 21.6% of participants from metformin only group and metformin + lifestyle changes group, which disappeared within 1 week of metformin administration. Adjusted by sex and puberty status, lean mass was significantly increased in lifestyle only group compared to controls no treatment and metformin only groups. Change in lean mass after 12 months' intervention: controls = +1.6 kg, lifestyle changes only = +3.98 kg, metformin only = ‐0.36 kg, metformin + lifestyle changes = ‐0.37 kg. 12 months' metformin treatment with lifestyle modification was effective and safe method reducing BMI and waist circumference in overweight/obese children and adolescents, superior to that of lifestyle changes alone Correspondence with author: the results presented in the poster are only partial results of a larger trial, where these data are currently being analysed. They aim to publish the results in a publication and as part of a PhD thesis

"‐" denotes not reported.

ACE: angiotensin converting enzyme; ALT: alanine transaminase; AST: aspartate transaminase; BMI: body mass index; GFR: glomerular filtration rate; HbA1c: haemoglobin A1c; HBV: hepatitis B virus; HCV: hepatitis C virus; HIV: human immunodeficiency virus; HOMA‐IR: homeostasis model assessment for insulin resistance; IOTF: International Obesity Task Force; min: minute; SD: standard deviation; SDS: standard deviation score.