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ObesityPhase 3MetVoorMinNCT01487993

Metformin in Obese Children and Adolescents

A Phase 3 study testing Metformin and Lifestyle intervention in people with Obesity and Insulin Resistance, run by St. Antonius Hospital at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 10 to 16 years
Conditions the study is for
Obesity, Insulin Resistance
What is being tested?
Metformin and Lifestyle intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
2 sitesNetherlands
Study dates
Aug 2011to 28 Feb 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Jeroen Bosch Hospital

    's-Hertogenbosch

  • St. Antonius Hospital

    Nieuwegein, 3430EM

Other trials in Netherlands

About this study

Official title: An Efficacy, Safety and Pharmacokinetic Study on the Short-term and Long-term Use of Metformin in Obese Children and Adolescents

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

Read the 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.

Being tested
Metformin, Lifestyle intervention
Keywords
Obesity, Children, Adolescents, Metformin, Insulin resistance
Medical subject headings
Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called Glucophage

    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 interventionBehavioural

    Lifestyle intervention: 18 months physical therapy and dietary advice

Study groups in NCT01487993
Study groupRoleWhat they receive
MetforminActive comparatorMetformin with lifestyle intervention during 18 months
Receives: Drug: Metformin; Behavioral: Lifestyle intervention
PlaceboPlacebo comparatorPlacebo and lifestyle intervention during 18 months
Receives: Behavioral: Lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in BMI from baseline

    Change in BMI after part 1 (double blind) and part 2 ( follow-up)

    Measured: 18 months and 36 months

  2. Change in Insulin resistance from baseline

    calculated by the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR).

    Measured: 3; 6; 9; 12; 15; 18; 24; 30 and 36 months

Secondary outcomes (13)

  1. Renal and hepatic function

    creatinine and alat

    Measured: 3; 6; 9; 12; 15; 18; 24; 30 and 36 months

  2. Tolerability

    The amount of reported adverse effects, in relation to the achieved dose level.

    Measured: 3; 6; 9; 12; 15; 18; 24; 30 and 36 months

  3. Pharmacokinetics (PK)-parameters: clearance (ml/min)

    Clearance where applicable expressed per body weight, age category, Tanner Stage and gender, clearance will be determined with a two-compartment pharmacokinetic model using non linear mixed effect modelling.

    Measured: 9 months

  4. Body fat percentage

    Measured: 0, 9, 18 and 36 months

  5. Physical fitness

    Measured: 0, 9, 18 and 36 months

  6. Quality of life

    Measured: 0, 9, 18 and 36 months

  7. Long term efficacy

    Based on BMI and HOMA-IR values

    Measured: 36 months

  8. Long-term safety

    Renal and hepatic function after 36 months of metformin use

    Measured: 36 months

  9. Long-term tolerability

    The amount of adverse effects after 36 months

    Measured: 36 months

  10. Microvascular complications

    Measured as micro-albuminuria

    Measured: 36 months

  11. Macrovascular complications

    Measured with Pulse Wave Velocity and Augmentation Index.

    Measured: 36 monthts

  12. Development of T2DM

    Measured: 36 months

  13. PK-parameters: volume of distribution (liters)

    Volume of distribution, where applicable expressed per body weight, age category, Tanner Stage and gender, volume of distribution will be determined with a two-compartment pharmacokinetic model using non linear mixed effect modelling.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionAug 2015
  4. Study completion28 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01487993
Sponsor's protocol ID
Metformin 2011-6
Other IDs
2010-023980-17
Acronym
MetVoorMin
Status last verified
Apr 2017
First submitted
20 Oct 2011
Last updated
27 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • van Rongen A, van der Aa MP, Matic M, van Schaik RHN, Deneer VHM, van der Vorst MM, Knibbe CAJ. Increased Metformin Clearance in Overweight and Obese Adolescents: A Pharmacokinetic Substudy of a Randomized Controlled Trial. Paediatr Drugs. 2018 Aug;20(4):365-374. doi: 10.1007/s40272-018-0293-1.

    PubMed 29748932

  • van der Aa MP, Hoving V, van de Garde EM, de Boer A, Knibbe CA, van der Vorst MM. The Effect of Eighteen-Month Metformin Treatment in Obese Adolescents: Comparison of Results Obtained in Daily Practice with Results from a Clinical Trial. J Obes. 2016;2016:7852648. doi: 10.1155/2016/7852648. Epub 2016 Dec 22.

    PubMed 28101379

  • van der Aa MP, Elst MA, van Mil EG, Knibbe CA, van der Vorst MM. METFORMIN: an efficacy, safety and pharmacokinetic study on the short-term and long-term use in obese children and adolescents - study protocol of a randomized controlled study. Trials. 2014 Jun 5;15:207. doi: 10.1186/1745-6215-15-207.

    PubMed 24899137

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin and Lifestyle intervention in people with Obesity and Insulin Resistance, run by St. Antonius Hospital at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in BMI from baseline (time frame: 18 months and 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01487993, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.

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