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

Obesity in children and adolescents: complications, associated risks and early intervention (lifestyle changes and insulin sensitivity improving medicine (metformin) effectiveness and safety evaluation) - OCA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006352-36-LT

Enrollment

100

Registered

2013-01-14

Start date

2013-04-11

Completion date

Unknown

Last updated

2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The aim of our study is to establish the effectivenes and safety of metformin use in pediatric obese population

Interventions

Trade Name: Metforal 500 mg / tablet Product Name: Metforal Product Code: LT/1/2000/1230/003 Pharmaceutical Form: Tablet INN or Proposed INN: METFORMIN CAS Number: 657-24-9 Other descriptive name: M

Eligibility

Sex/Gender

All

Inclusion criteria

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

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;

Design outcomes

Primary

Measure	Time frame
Main Objective: The main aim of our study is to investigate metformin influence on BMI in obese children ;Secondary Objective: Other aims of our study are to establish metformin efficacy and safety for pediatric obesity treatment; to evaluate the metformin, physical activity and diet influence on weight, hormone, glucose and lipid profiles, insulin sensitivity, metabolic complications risks.;Primary end point(s): BMI decrease; ;Timepoint(s) of evaluation of this end point: The timepoint of the evaluation is 12 months	—

Measure

Time frame

Main Objective: The main aim of our study is to investigate metformin influence on BMI in obese children ;Secondary Objective: Other aims of our study are to establish metformin efficacy and safety for pediatric obesity treatment; to evaluate the metformin, physical activity and diet influence on weight, hormone, glucose and lipid profiles, insulin sensitivity, metabolic complications risks.;Primary end point(s): BMI decrease; ;Timepoint(s) of evaluation of this end point: The timepoint of the evaluation is 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): weight, circumferences, skin folds decrease; glucose, insulin and HOMA-IR decrease ; hormone and lipid profile improvment;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Lithuania

Contacts

Public ContactRasa Verkauskiene

Lithuanian University of Health Sciences, Endocrinology Department

rasa.verkauskiene@kaunoklinikos.lt37037326816

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026