Metformin in Obese Children with Abnormal Glucose and Insulin Status

ISRCTN ISRCTN19517475
DOI https://doi.org/10.1186/ISRCTN19517475
Secondary identifying numbers N0453162755
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
07/01/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims:
Childhood obesity has increased globally over the last two decades and it is linked to an increase in the diagnosis of type 2 diabetes (T2D) in childhood and adolescence. T2D is a condition that was previously only diagnosed in adults and was very rare in children. T2D is associated with high blood glucose levels and with other significant health problems, such as increased risk of heart problems, eye problems, kidney problems, nerve problems and premature death. It is therefore important to try to prevent the onset of T2D in obese children and adolescents.
Metformin is a drug that reduces the risk for T2D in obese adults, but the evidence in obese children and young people is inconclusive. The aims of the MOCA trial were to find out how well metformin works in obese children and adolescents.

Who can participate?
One hundred and fifty-one obese children and young people took part in the trial with 74 in the metformin group and 77 in the dummy (placebo) group. 67.5% were female, and 23.8% were British Asian or Afro-Caribbean. The age range was 8-18 years, with an average age of 13.7 years.

What does the study involve?
The MOCA trial was a prospective clinical trial over six months, where the participants were put into two groups randomly by chance. One group was given treatment with metformin and one group was given a dummy pill (placebo). Neither the participant or study investigator knew whether the participant was taking the metformin or placebo. All the participants were obese and they visited the trial centre at the start of the trial, after 3 months treatment and after 6 months treatment (the end). At each visit they had blood tests done and their weight and height was measured so that their body mass index (BMI) could be calculated (weight in kg/height in m2). The BMI was then adjusted for age and sex to give the body mass index standard deviation score (BMI-SDS).

What are the possible benefits and risks of participating?
Benefits of participating include a potential reduction in long-term risk of T2D and associated health problems. The risks associated with participating were small as metformin is safe and well tolerated with minimal side-effects in obese children and adolescents.

Where is the study run from?
The trial took place in six UK paediatric endocrine centres.

When is the study starting and how long is it expected to run for?
The study began in January 2005 and ended in June 2009.

Who is funding the study?
Central Manchester University Hospitals NHS Foundation Trust and the Child Growth Foundation UK.

Who is the main contact?
Peter E Clayton MD MRCP FRCPCH
peter.clayton@manchester.ac.uk

Contact information

Dr Peter Clayton
Scientific

Manchester Academic Health Sciences Centre
Paediatric Endocrinology
5th Floor (Research)
Royal Manchester Children's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Phone + 44 (0)161 701 6949
Email peter.clayton@manchester.ac.uk

Study information

Study designMulticentre prospective randomised placebo controlled
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet 'Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymMOCA
Study objectivesTo study the effects of metformin in children and adolescents with fasting hyperinsuliaemia and/or impaired glucose tolerance.
Ethics approval(s)Added 16 December 2008: Salford and Trafford Research Ethics Committee, 13/09/2004, REC reference no: 04/Q1404/65.
Health condition(s) or problem(s) studiedNutritional, Metabolic, Endocrine: Obesity
InterventionPrevious interventions:
1. Metformin (500mg)
2. Placebo

Current interventions as of 15/12/2008:
1. Metformin 1g mane, 500mg nocte
2. Placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)metformin
Primary outcome measureReduction in BMI SDS.
Secondary outcome measuresAdded 16 December 2008: fasting and 2 hr insulin and glucose levels on OGTT, measures of insulin resistance, fasting lipids, CRP, adiponectin, leptin, resistin, blood pressure.
Overall study start date01/01/2005
Completion date30/06/2009

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit9 Years
Upper age limit18 Years
SexNot Specified
Target number of participants40 in each group, 80 in total.
Key inclusion criteriaPrior to 16 December 2008:
80 patients aged between 9-18 years old

As of 16 December 2008:
1. Pubertal and post-pubertal children : Fasting insulin > 26 mIU/l
2. Pre-pubertal children : Fasting insulin > 15 mIU/l
3. 120 minute insulin > 89 mIu/l
AND/OR
Impaired glucose tolerance ie: OGTT 2hr plasma glucose value > or = 7.8 to <11.1 (+/- impaired fasting glucose > or = 6.1 to < 7)
Key exclusion criteriaAdded 16 December 2008:

1. Glycosuria
2. Ketonuria
3. Other chronic illness or chromosomal abnormality or syndrome eg. Prader-Willi, Turner’s syndrome, hypothyroidism
4. Renal insufficiency
5. Hepatic dysfunction (raised ALT >2 SDS above mean)
6. Chronic diarrhoea
7. Previous episode lactic acidosis
Date of first enrolment01/01/2005
Date of final enrolment30/06/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Manchester Academic Health Sciences Centre
Manchester
M13 9WL
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Charity

Central Manchester and Manchester Children's University Hospitals NHS Trust (UK) - NHS R&D Support Funding

No information available

Child Growth Foundation

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2013 Yes No