Obesity in Children and Adolescents: Associated Risks and Early Intervention

Phase 3

Completed

• Conditions: Obesity
• Interventions: Drug: Metformin

• Registration Number: NCT01677923
• Lead Sponsor: Lithuanian University of Health Sciences

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.

Study Timeline

• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-09-03
• Study Start: 2013-05
• Primary Completion: 2014-04
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention with Metformin	Metformin	Intensive physical activity course twice per week and monthly diet control by dietitian plus Metformin treatment.
Control with Metformin	Metformin	Conventional management of obesity including basic instructions on diet and physical activity plus Metformin treatment

Primary Outcome Measures

Name	Time	Method
Body mass index changes	12 months	decrease in body mass index

Secondary Outcome Measures

Name	Time	Method
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
Metabolic syndrome	12 months	Metabolic syndrome prevalence and risks decrease
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

Trial Locations

Locations (1)

Rasa Verkauskiene; 🇱🇹 Kaunas, Eiveniu str. 2, Lithuania