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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 baseline

Change in Insulin resistance from baseline

Secondary outcome:

Renal and hepatic function

Tolerability

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

Page last updated: August 23, 2015

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