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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Lithuanian University of Health Sciences
Sponsor:
Information provided by (Responsible Party):
Rasa Verkauskiene, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01677923
First received: July 30, 2012
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3: Effect of Diet, Physical Activity and Insulin Sensitizer Metformin on Obesity and Associated Risks in Children and Adolescents.

Resource links provided by NLM:


Further study details as provided by Lithuanian University of Health Sciences:

Primary Outcome Measures:
  • Body mass index changes [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    decrease in body mass index


Secondary Outcome Measures:
  • Glucose homeostasis [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    Insulin sensitivity increase, homeostasis model assessment (HOMA-IR) decrease, insulin and glucose concentrations normalisation

  • Lipid profile [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Lipid profile normalisation

  • Metabolic syndrome [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Metabolic syndrome prevalence and risks decrease

  • Hepatosteatosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Hepatosteatosis prevalence decrease and liver function improvement, hepatic enzymes normalisation

  • Polycystic ovary syndrome (PCOS) and hyperandrogenism in females [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    PCOS clinical symptoms regression, menstrual cycle normalisation, hirsutism, androgens levels decreasing and estrogen, sex hormone-binding globulin (SHBG) levels increasing


Other Outcome Measures:
  • safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    how many patients will have adverse events and withdraw the Metformin due to their intolerance or clinical / biochemical relapse


Estimated Enrollment: 400
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Metforal
Experimental: Intervention with metformin
intensive physical activity course twice per week and monthly diet control by dietician plus Metformin treatment.
Drug: Metformin
Metformin 500 mg BID for 12 months
Other Name: Metforal
No Intervention: Intervention without metformin
intensive physical activity course twice per week and monthly diet control by dietician

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

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677923

Contacts
Contact: Rasa Verkauskiene, Professor 00370-37-327097 rasa.verkauskiene@kaunoklinikos.lt
Contact: Natalija Smetanina 00370-37-326801 natalija.smetanina@gmail.com

Locations
Lithuania
Rasa Verkauskiene Recruiting
Kaunas, Eiveniu str. 2, Lithuania, LT50009
Contact: Rasa Verkauskiene, Professor    00370-37-327097    rasa.verkauskiene@kaunoklinikos.lt   
Sub-Investigator: Natalija Smetanina         
Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
Study Chair: Rasa Verkauskiene, Professor Lithuanian University of Health Sciences Hospital, Endocrinology Unit
  More Information

No publications provided

Responsible Party: Rasa Verkauskiene, Professor, Head of Endocrinology Unit and Institute in Lithuanian UHS, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT01677923     History of Changes
Other Study ID Numbers: BE-2-1
Study First Received: July 30, 2012
Last Updated: September 25, 2013
Health Authority: Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Lithuanian University of Health Sciences:
weight
body mass index
lipid profile
glucose profile

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014