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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.
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.
nd group - intensive diet and physical activity group: Children will be seen
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control without Metformin | No Intervention | Conventional management of obesity including basic instructions on diet and physical activity | |
| Control with Metformin | Experimental | Conventional management of obesity including basic instructions on diet and physical activity plus Metformin treatment |
|
| Intervention with Metformin | Experimental | Intensive physical activity course twice per week and monthly diet control by dietitian plus Metformin treatment. |
|
| Intervention without Metformin | No Intervention | Intensive physical activity course twice per week and monthly diet control by dietitian |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin 500 mg BID for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index changes | decrease in body mass index | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose homeostasis | Insulin sensitivity increase, homeostasis model assessment (HOMA-IR) decrease, insulin and glucose concentrations normalisation | 12 month |
| Lipid profile | Lipid profile normalisation |
| Measure | Description | Time Frame |
|---|---|---|
| safety | how many patients will have adverse events and withdraw the Metformin due to their intolerance or clinical / biochemical relapse | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rasa Verkauskiene, Professor | Lithuanian University of Health Sciences Hospital, Endocrinology Unit | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rasa Verkauskiene | Kaunas | Eiveniu Str. 2 | LT50009 | Lithuania |
Study results are in progress with statistical analysis
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| 12 months |
| Metabolic syndrome | Metabolic syndrome prevalence and risks decrease | 12 months |
| Hepatosteatosis | Hepatosteatosis prevalence decrease and liver function improvement, hepatic enzymes normalisation | 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 | 12 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |