Metformin, diet and physical activity influence on the overweight and obesity in childre

Phase 1

• Conditions: The aim of our study is to establish the effectivenes and safety of metformin use in pediatric obese population; to assess the prevalence of insulin resistance, metabolic syndrome, polycystic ovary syndrome (PCOS), impaired glucose tolerance (IGT) and type 2 diabetes mellitus (T2DM) among overweight and obese children and adolescents in Lithuania, and to determine the effect of targeted interventions (lifestyle and metformin) in controlling obesity and associated diseases risk.; MedDRA version: 14.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-006352-36-LT
• Lead Sponsor: ithuanian University of Health Sciences, Endocrinology Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-14
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Age 10-17 yrs;
•BMI > 85th percentile for age and gender (by IOTF);
•Living in Kaunas and its region;
•No obvious chronic diseases;
•Not on long-term steroid oral / IV treatment;
•Childbearing age ladies using contraception;
•Informed consent of the patient and parents (official caregivers);
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Age less than 10 or above 17 yrs;
•Diagnosis of type 1 diabetes;
•Chronic illness that may affect physical activity, hormone and metabolic profile;
•Insulin treatment;
•Steroid treatment;
•Planning to move from Kaunas or its region in the period of 1 year;
•Childbearing age ladies non- using contraception, pregnancy planning;
•Protocol refused by the patient or his parents;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified