Obesity in children and adolescents: complications, associated risks and early intervention (lifestyle changes and insulin sensitivity improving medicine (metformin) effectiveness and safety evaluation)

INTERVENTION: Trade Name: Metforal 500 mg / tablet Product Name: Metforal Product Code: LT/1/2000/1230/003 Pharmaceutical Form: Tablet INN or Proposed INN: METFORMIN CAS Number: 657‐24‐9 Other descriptive name: Metforal Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ CONDITION: The aim of our study is to establish the effectivenes and safety of metformin use in pediatric obese population; to assess the prevalence of insulin resistance, metabolic syndrome, polycystic ovary syndrome (PCOS), impaired glucose tolerance (IGT) and type 2 diabetes mellitus (T2DM) among overweight and obese children and adolescents in Lithuania, and to determine the effect of targeted interventions (lifestyle and metformin) in controlling obesity and associated diseases risk. ; MedDRA version: 14.1 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 ‐ Metabolism and nutrition disorders ; MedDRA version: 14.1 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 ‐ Metabolism and nutrition disorders Therapeutic area: Diseases [C] ‐ Hormonal diseases [C19] PRIMARY OUTCOME: Main Objective: The main aim of our study is to investigate metformin influence on BMI in obese children Primary end point(s): BMI decrease; Secondary Objective: Other aims of our study are to establish metformin efficacy and safety for pediatric obesity treatment; to evaluate the metformin, physical activity and diet influence on weight, hormone, glucose and lipid profiles, insulin sensitivity, metabolic complications risks. Timepoint(s) of evaluation of this end point: The timepoint of the evaluation is 12 months SECONDARY OUTCOME: Secondary end point(s): weight, circumferences, skin folds decrease; ; glucose, insulin and HOMA‐IR decrease ; ; hormone and lipid profile improvment Timepoint(s) of evaluation of this end point: 12 months INCLUSION CRITERIA: • Age 10‐17 yrs; • BMI > 85th percentile for age and gender (by IOTF); • Living in Kaunas and its region; • No obvious chronic diseases; • Not on long‐term steroid oral / IV treatment; • Childbearing age ladies using contraception; • Informed consent of the patient and parents (official caregivers); Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range