Obesity in Children and Adolescents: Associated Risks and Early Intervention

Obesity Clinical Trial

— OCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677923
• Other study ID #: BE-2-1
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2012
• Last updated: March 2, 2016
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics CommitteeLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Metformin
Metformin 500 mg BID for 12 months

Locations

Country	Name	City	State
Lithuania	Rasa Verkauskiene	Kaunas	Eiveniu str. 2

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety	how many patients will have adverse events and withdraw the Metformin due to their intolerance or clinical / biochemical relapse	12 months	Yes
Primary	Body mass index changes	decrease in body mass index	12 months	Yes
Secondary	Glucose homeostasis	Insulin sensitivity increase, homeostasis model assessment (HOMA-IR) decrease, insulin and glucose concentrations normalisation	12 month	Yes
Secondary	Lipid profile	Lipid profile normalisation	12 months	Yes
Secondary	Metabolic syndrome	Metabolic syndrome prevalence and risks decrease	12 months	Yes
Secondary	Hepatosteatosis	Hepatosteatosis prevalence decrease and liver function improvement, hepatic enzymes normalisation	12 months	Yes
Secondary	Polycystic ovary syndrome (PCOS) and hyperandrogenism in females	PCOS clinical symptoms regression, menstrual cycle normalisation, hirsutism, androgens levels decreasing and estrogen, sex hormone-binding globulin (SHBG) levels increasing	12 months	Yes