Skip to main content
OpenTrials
Completed

NCT Number: NCT01677923

Obesity in Children and Adolescents: Associated Risks and Early Intervention

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rasa Verkauskiene

Kaunas, Eiveniu Str. 2, LT50009, Lithuania

About this study

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.

  • 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.
  • nd group - intensive diet and physical activity group: Children will be seen
  • by a dietician once a month for diet re-evaluation;
  • physical therapist, who will give physical activity course twice a week (1 h each).
  • pediatric endocrinologist every 3 months. Clinical and laboratory evaluation after 12 months of intervention.
  • 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
  • a dietician once a month for diet re-evaluation;
  • physical therapist, who will give physical activity course twice a week (1 h each);
  • pediatric endocrinologist every 3 month. Clinical and laboratory evaluation after 12 months of intervention.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

metformin

Drug

Metformin 500 mg BID for 12 months

Other names: Metforal

Primary outcomes

  1. Body mass index changes

    Time frame: 12 months

    decrease in body mass index

Secondary outcomes

  1. Glucose homeostasis

    Time frame: 12 month

    Insulin sensitivity increase, homeostasis model assessment (HOMA-IR) decrease, insulin and glucose concentrations normalisation

  2. Lipid profile

    Time frame: 12 months

    Lipid profile normalisation

  3. Metabolic syndrome

    Time frame: 12 months

    Metabolic syndrome prevalence and risks decrease

  4. Hepatosteatosis

    Time frame: 12 months

    Hepatosteatosis prevalence decrease and liver function improvement, hepatic enzymes normalisation

  5. Polycystic ovary syndrome (PCOS) and hyperandrogenism in females

    Time frame: 12 months

    PCOS clinical symptoms regression, menstrual cycle normalisation, hirsutism, androgens levels decreasing and estrogen, sex hormone-binding globulin (SHBG) levels increasing

Other outcomes

  1. safety

    Time frame: 12 months

    how many patients will have adverse events and withdraw the Metformin due to their intolerance or clinical / biochemical relapse

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Acronym: OCA

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Sep 3, 2012
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.