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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Metformin

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 Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 3

Contacts and Locations

Study Locations

• Lithuania
  • Eiveniu str. 2
    • Kaunas, Eiveniu str. 2, Lithuania, LT50009
      • Rasa Verkauskiene

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control without Metformin; Conventional management of obesity including basic instructions on diet and physical activity
Experimental: Control with Metformin; Conventional management of obesity including basic instructions on diet and physical activity plus Metformin treatment	Drug: Metformin; Metformin 500 mg BID for 12 months; Other Names: Metforal
Experimental: Intervention with Metformin; Intensive physical activity course twice per week and monthly diet control by dietitian plus Metformin treatment.	Drug: Metformin; Metformin 500 mg BID for 12 months; Other Names: Metforal
No Intervention: Intervention without Metformin; Intensive physical activity course twice per week and monthly diet control by dietitian

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index changes	decrease in body mass index	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose homeostasis	Insulin sensitivity increase, homeostasis model assessment (HOMA-IR) decrease, insulin and glucose concentrations normalisation	12 month
Lipid profile	Lipid profile normalisation	12 months
Metabolic syndrome	Metabolic syndrome prevalence and risks decrease	12 months
Hepatosteatosis	Hepatosteatosis prevalence decrease and liver function improvement, hepatic enzymes normalisation	12 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety	how many patients will have adverse events and withdraw the Metformin due to their intolerance or clinical / biochemical relapse	12 months

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Investigators: Study Chair: Rasa Verkauskiene, Professor, Lithuanian University of Health Sciences Hospital, Endocrinology Unit

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 30, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Estimate): March 4, 2016
• Last Update Submitted That Met QC Criteria: March 2, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: body mass index; weight; lipid profile; glucose profile
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: BE-2-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Study results are in progress with statistical analysis