Obesity
Conditions
Keywords
weight, body mass index, lipid profile, glucose profile
Brief summary
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
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.
Interventions
DRUGMetformin
Metformin 500 mg BID for 12 months
Sponsors
Lithuanian University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index changes | 12 months | decrease in body mass index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose homeostasis | 12 month | Insulin sensitivity increase, homeostasis model assessment (HOMA-IR) decrease, insulin and glucose concentrations normalisation |
| Lipid profile | 12 months | Lipid profile normalisation |
| Hepatosteatosis | 12 months | Hepatosteatosis prevalence decrease and liver function improvement, hepatic enzymes normalisation |
| Polycystic ovary syndrome (PCOS) and hyperandrogenism in females | 12 months | PCOS clinical symptoms regression, menstrual cycle normalisation, hirsutism, androgens levels decreasing and estrogen, sex hormone-binding globulin (SHBG) levels increasing |
| Metabolic syndrome | 12 months | Metabolic syndrome prevalence and risks decrease |
Other
| Measure | Time frame | Description |
|---|---|---|
| safety | 12 months | how many patients will have adverse events and withdraw the Metformin due to their intolerance or clinical / biochemical relapse |
Countries
Lithuania
Outcome results
None listed