Rasa Verkauskiene
Kaunas, Eiveniu Str. 2, LT50009, Lithuania
NCT Number: NCT01677923
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.
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Notify Me10 year–18 year
All sexes
Interventional
Phase 3
Kaunas, Eiveniu Str. 2, LT50009, Lithuania
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Metformin 500 mg BID for 12 months
Other names: Metforal
Time frame: 12 months
decrease in body mass index
Time frame: 12 month
Insulin sensitivity increase, homeostasis model assessment (HOMA-IR) decrease, insulin and glucose concentrations normalisation
Time frame: 12 months
Lipid profile normalisation
Time frame: 12 months
Metabolic syndrome prevalence and risks decrease
Time frame: 12 months
Hepatosteatosis prevalence decrease and liver function improvement, hepatic enzymes normalisation
Time frame: 12 months
PCOS clinical symptoms regression, menstrual cycle normalisation, hirsutism, androgens levels decreasing and estrogen, sex hormone-binding globulin (SHBG) levels increasing
Time frame: 12 months
how many patients will have adverse events and withdraw the Metformin due to their intolerance or clinical / biochemical relapse
Lithuanian University of Health Sciences
Other
Phase 3: Effect of Diet, Physical Activity and Insulin Sensitizer Metformin on Obesity and Associated Risks in Children and Adolescents.
Acronym: OCA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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