Obesity in Children and Adolescents: Associated Risks and Early Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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 by a dietician once a month for diet re-evaluation; physical therapist, who will give physical activity course twice a week (1 h each). pediatric endocrinologist every 3 months. Clinical and laboratory evaluation after 12 months of intervention. 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 a dietician once a month for diet re-evaluation; physical therapist, who will give physical activity course twice a week (1 h each); pediatric endocrinologist every 3 month. Clinical and laboratory evaluation after 12 months of intervention. 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.

Official Title
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Phase 3: Effect of Diet, Physical Activity and Insulin Sensitizer Metformin on Obesity and Associated Risks in Children and Adolescents.

Conditions
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Obesity

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 10-17 yrs; Weight > 85th percentile for age and gender (by IOTF); Living in Kaunas and its region; No obvious chronic diseases; Not on steroid or other long-term treatment; Informed consent of the patient and parents (official caregivers); Exclusion Criteria: Age less than 10 or above 17 yrs; Diagnosis of type 1 diabetes; Chronic illness that may affect physical activity and metabolic profile; Insulin treatment; Steroid treatment; Planning to move from Kaunas or its region in the period of 1 year; Protocol refused by the patient or his parents;

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control without Metformin<br>Conventional management of obesity including basic instructions on diet and physical activity | |
| Experimental: Control with Metformin<br>Conventional management of obesity including basic instructions on diet and physical activity plus Metformin treatment | Drug: Metformin<br>* Metformin 500 mg BID for 12 months<br>* Other names: Metforal;|
| Experimental: Intervention with Metformin<br>Intensive physical activity course twice per week and monthly diet control by dietitian plus Metformin treatment. | Drug: Metformin<br>* Metformin 500 mg BID for 12 months<br>* Other names: Metforal;|
| No Intervention: Intervention without Metformin<br>Intensive physical activity course twice per week and monthly diet control by dietitian | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index changes | decrease in body mass index | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight, body mass index, lipid profile, glucose profile