Metformin in Obese Children and Adolescents
Information source: St. Antonius Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Insulin Resistance
Intervention: Metformin (Drug); Lifestyle intervention (Behavioral)
Phase: Phase 3
Status: Recruiting
Sponsored by: St. Antonius Hospital Official(s) and/or principal investigator(s): Marja MJ van der Vorst, MD, PhD, Principal Investigator, Affiliation: St. Antonius Hospital
Overall contact: Marieke MAJ Elst, MD, Phone: +31306093775, Email: m.elst@antoniusziekenhuis.nl
Summary
The purpose of this study is to determine whether metformin is effective in reducing BMI and
insulin resistance in obese children and adolescents.
Clinical Details
Official title: An Efficacy, Safety and Pharmacokinetic Study on the Short-term and Long-term Use of Metformin in Obese Children and Adolescents
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change in BMI from baselineChange in Insulin resistance from baseline
Secondary outcome: Renal and hepatic functionTolerability Pharmacokinetics (PK)-parameters: clearance (ml/min) Body fat percentage Physical fitness Quality of life Long term efficacy Long-term safety Long-term tolerability Microvascular complications Macrovascular complications Development of T2DM PK-parameters: volume of distribution (liters)
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 metabolic complications, such as insulin resistance, which can progress
via impaired fasted glucose and impaired glucose tolerance to type 2 diabetes mellitus
(T2DM) and to the development of micro- and macro-vascular complications.
Metformin, an oral anti-diabetic licensed for T2DM for adults and children from 10 years
onwards, is already used off label in obese children and adolescents with insulin
resistance, even though the specific effects of metformin in these obese children and
adolescents have not been elucidated, particularly upon long-term use.
The rationale for this study is based on the hypothesis that metformin may reduce body mass
index (BMI), insulin resistance and percentage of body-fat in obese children and adolescents
with insulin resistance. Further more it is anticipated that metformin may delay the
progression to T2DM and thereby micro- and macro-vascular complications in obese children
and adolescents with insulin resistance.
Eligibility
Minimum age: 10 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Marieke MAJ Elst, MD, Phone: +31306093775, Email: m.elst@antoniusziekenhuis.nl
Jeroen Bosch Hospital, 's Hertogenbosch, Netherlands; Recruiting Marieke AJ Elst, MD, Phone: +31 30 609 3775, Email: m.elst@antoniusziekenhuis.nl Edgar GAH van Mil, MD, PhD, Phone: +31 73 553 2304, Email: e.g.vanmil@jbz.nl Edgar GAH van Mil, MD, PhD, Principal Investigator Marieke AJ Elst, MD, Sub-Investigator
St. Antonius Hospital, Nieuwegein 3430EM, Netherlands; Recruiting Marieke AJ Elst, MD, Phone: +31306093775, Email: m.elst@antoniusziekenhuis.nl Marja MJ van der Vorst, MD, PhD, Phone: +31306096325, Email: m.van.der.vorst@antoniusziekenhuis.nl Marja MJ van der Vorst, MD, PhD, Principal Investigator Marloes P van der Aa, MD, Sub-Investigator Marieke AJ Elst, MD, Sub-Investigator
Additional Information
Starting date: August 2011
Last updated: August 21, 2013
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