Status:
COMPLETED
Metformin in Obese Children and Adolescents
Lead Sponsor:
St. Antonius Hospital
Collaborating Sponsors:
Jeroen Bosch Ziekenhuis
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
10-16 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether metformin is effective in reducing BMI and insulin resistance in obese children and adolescents.
Detailed Description
The prevalence of obesity in children and adolescents is increasing rapidly and is associated with significant medical and psychosocial consequences persisting into adulthood. Obesity may lead to met...
Eligibility Criteria
Inclusion
- Age ≥ 10 and ≤ 16 years at study entry
- Caucasian descent
- Obesity defined as BMI-SDS \> 2.3
- Insulin resistance defined as HOMA-IR ≥ 3.4.
- An obtained informed consent from subjects and parents/caregivers.
Exclusion
- Presence of T2DM (American Diabetes Association criteria)
- Presence of endocrine disorders with steroid therapy
- Suspicion of polycystic ovarium syndrome;
- Height \< -1.3 SD of target height;
- Syndrome disorders with or without mental retardation;
- Use of anti-hyperglycaemic drugs;
- Pregnancy (pregnancy test will be performed, if applicable);
- (History of) alcohol abuse;
- Impaired renal and/or hepatic function (defined as GFR \< 80 ml/min. GFR=40 x length (cm) / serumcreatinin (μmol/l and ALAT \>150% of normal value for age);
- Use of ritonavir; use of ACE inhibitors;
- Insufficient knowledge of the Dutch language.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2017
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01487993
Start Date
August 1 2011
End Date
February 28 2017
Last Update
April 27 2017
Active Locations (2)
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1
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
2
St. Antonius Hospital
Nieuwegein, Netherlands, 3430EM