Obesity in Children and Adolescents: Associated Risks and Early Intervention (OCA)

Lithuanian University of Health Sciences

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01677923

BE-2-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

182 participants in 4 patient groups

Control without Metformin

No Intervention group

Description:

Conventional management of obesity including basic instructions on diet and physical activity

Control with Metformin

Experimental group

Description:

Conventional management of obesity including basic instructions on diet and physical activity plus Metformin treatment

Treatment:

Drug: Metformin

Intervention with Metformin

Experimental group

Description:

Intensive physical activity course twice per week and monthly diet control by dietitian plus Metformin treatment.

Treatment:

Drug: Metformin

Intervention without Metformin

No Intervention group

Description:

Intensive physical activity course twice per week and monthly diet control by dietitian