NCT01677923

Obesity in Children and Adolescents: Associated Risks and Early Intervention

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Lithuanian University of Health Sciences · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Metformin	Metformin 500 mg BID for 12 months

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-04-01
• Completion: 2015-12-01
• First posted: 2012-09-03
• Last updated: 2016-03-04

Locations

1 site across 1 country: Lithuania