Obesity in Children and Adolescents: Associated Risks and Early Intervention

NCT ID: NCT01677923

Last Updated: 2016-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control without Metformin

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Control with Metformin

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

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin 500 mg BID for 12 months

Intervention with Metformin

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

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin 500 mg BID for 12 months

Intervention without Metformin

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Metformin

Metformin 500 mg BID for 12 months

Intervention Type: DRUG

Other Intervention Names

Metforal

Eligibility Criteria

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;

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Rasa Verkauskiene

Professor, Head of Department and Institute of Endocrinology, Lithuanian UHS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rasa Verkauskiene, Professor

Role: STUDY_CHAIR

Lithuanian University of Health Sciences Hospital, Endocrinology Unit

Locations

Rasa Verkauskiene

Kaunas, Eiveniu Str. 2, Lithuania

Countries

Lithuania

Other Identifiers

BE-2-1

Identifier Type: -

Identifier Source: org_study_id