The investigators hypothesize that Metformin decreases weight, normalizes lipid profile and increases insulin sensitivity; the study team hope to get better effect of weight decrease and metabolic processes repair in the intensive treatment group with intervention of physical activity, diet correction and Metformin use.
During the first visit, study participants would follow the clinical investigation (anthropometry, physical examination, blood tests (hormonal and biochemical state), bioimpedance, ultrasound evaluation) and be attributed into 4 groups (matched for age, gender, pubertal stage and BMI), 100 subjects in each group. 1. st group - control: during the first visit patients get standardized information on healthy lifestyle, diet and exercise. Next visit (control) will be scheduled for the clinical and laboratory evaluation after 12 months of intervention. 2. nd group - intensive diet and physical activity group: Children will be seen 1. by a dietician once a month for diet re-evaluation; 2. physical therapist, who will give physical activity course twice a week (1 h each). 3. pediatric endocrinologist every 3 months. Clinical and laboratory evaluation after 12 months of intervention. 3. rd group - intensive diet and physical activity group plus insulin sensitization: Metformin will be prescribed for this group of study children in the doses of 1000 mg/day Children will be seen by 1. a dietician once a month for diet re-evaluation; 2. physical therapist, who will give physical activity course twice a week (1 h each); 3. pediatric endocrinologist every 3 month. Clinical and laboratory evaluation after 12 months of intervention. 4. th group- insulin sensitization without intensive diet and physical activity. Metformin will be prescribed in the doses of 1000 mg/day after standardized information on healthy lifestyle, diet and exercise during the first visit only. This group of children will be seen by pediatric endocrinologist every 3 months. Intervention duration - 12 months. In the case of Metformin intolerance, children will continue the study in 2nd group. Clinical and laboratory evaluation after 12 months of intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Metformin 500 mg BID for 12 months
Rasa Verkauskiene
Kaunas, Eiveniu Str. 2, Lithuania
Body mass index changes
decrease in body mass index
Time frame: 12 months
Glucose homeostasis
Insulin sensitivity increase, homeostasis model assessment (HOMA-IR) decrease, insulin and glucose concentrations normalisation
Time frame: 12 month
Lipid profile
Lipid profile normalisation
Time frame: 12 months
Metabolic syndrome
Metabolic syndrome prevalence and risks decrease
Time frame: 12 months
Hepatosteatosis
Hepatosteatosis prevalence decrease and liver function improvement, hepatic enzymes normalisation
Time frame: 12 months
Polycystic ovary syndrome (PCOS) and hyperandrogenism in females
PCOS clinical symptoms regression, menstrual cycle normalisation, hirsutism, androgens levels decreasing and estrogen, sex hormone-binding globulin (SHBG) levels increasing
Time frame: 12 months
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