Clinical trial NCT01677923: Obesity in Children and Adolescents: Associated Risks and Early Intervention
Official title: Phase 3: Effect of Diet, Physical Activity and Insulin Sensitizer Metformin on Obesity and Associated Risks in Children and Adolescents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: weight
body mass index
lipid profile
glucose profile
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 182
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Body mass index changes
timeFrame: 12 months
Secondary outcomes:
measure: Glucose homeostasis
timeFrame: 12 month
measure: Lipid profile
timeFrame: 12 months
measure: Metabolic syndrome
timeFrame: 12 months
measure: Hepatosteatosis
timeFrame: 12 months
measure: Polycystic ovary syndrome (PCOS) and hyperandrogenism in females
timeFrame: 12 months
Other outcomes:
measure: safety
timeFrame: 12 months
Locations:
city: Kaunas
country: Lithuania
facility: Rasa Verkauskiene
state: Eiveniu str. 2
Study officials:
affiliation: Lithuanian University of Health Sciences Hospital, Endocrinology Unit
name: Rasa Verkauskiene, Professor
role: STUDY_CHAIR
References: