We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01677923
Recruitment Status : Completed
First Posted : September 3, 2012
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Metformin Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2013
Primary Completion Date : April 2014
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Metforal
No Intervention: Intervention without Metformin
Intensive physical activity course twice per week and monthly diet control by dietitian


Outcome Measures

Primary Outcome Measures :
  1. Body mass index changes [ Time Frame: 12 months ]
    decrease in body mass index


Secondary Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677923


Locations
Lithuania
Rasa Verkauskiene
Kaunas, Eiveniu str. 2, Lithuania, LT50009
Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
Study Chair: Rasa Verkauskiene, Professor Lithuanian University of Health Sciences Hospital, Endocrinology Unit
More Information

Responsible Party: Rasa Verkauskiene, Professor, Head of Department and Institute of Endocrinology, Lithuanian UHS, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT01677923     History of Changes
Other Study ID Numbers: BE-2-1
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study results are in progress with statistical analysis

Keywords provided by Rasa Verkauskiene, 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