Metformin in Obese Children and Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-02-28

Brief Summary

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The purpose of this study is to determine whether metformin is effective in reducing BMI and insulin resistance in obese children and adolescents.

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Detailed Description

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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.

Conditions

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Obesity Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Metformin

Metformin with lifestyle intervention during 18 months

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Oral administration, 500 mg daily at week 1. Every week metformin dosage increases with 500 mg, to a maximum dose of 1000 mg bid. This maximum dose will be administered till the end of the study.

Lifestyle intervention

Intervention Type BEHAVIORAL

Lifestyle intervention: 18 months physical therapy and dietary advice

Placebo

Placebo and lifestyle intervention during 18 months

Group Type PLACEBO_COMPARATOR

Lifestyle intervention

Intervention Type BEHAVIORAL

Lifestyle intervention: 18 months physical therapy and dietary advice

Interventions

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Metformin

Oral administration, 500 mg daily at week 1. Every week metformin dosage increases with 500 mg, to a maximum dose of 1000 mg bid. This maximum dose will be administered till the end of the study.

Intervention Type DRUG

Lifestyle intervention

Lifestyle intervention: 18 months physical therapy and dietary advice

Intervention Type BEHAVIORAL

Other Intervention Names

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Glucophage

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No