Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Peter Clayton
ORCID ID
Contact details
Manchester Academic Health Sciences Centre
Paediatric Endocrinology
5th Floor (Research)
Royal Manchester Children's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
+ 44 (0)161 701 6949
peter.clayton@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0453162755
Study information
Scientific title
Acronym
MOCA
Study hypothesis
To study the effects of metformin in children and adolescents with fasting hyperinsuliaemia and/or impaired glucose tolerance.
Ethics approval
Added 16 December 2008: Salford and Trafford Research Ethics Committee, 13/09/2004, REC reference no: 04/Q1404/65.
Study design
Multicentre prospective randomised placebo controlled
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
'Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Obesity
Intervention
Previous interventions:
1. Metformin (500mg)
2. Placebo
Current interventions as of 15/12/2008:
1. Metformin 1g mane, 500mg nocte
2. Placebo
Intervention type
Drug
Phase
Not Specified
Drug names
metformin
Primary outcome measure
Reduction in BMI SDS.
Secondary outcome measures
Added 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 trial start date
01/01/2005
Overall trial end date
30/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Prior 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)
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
40 in each group, 80 in total.
Participant exclusion criteria
Added 16 December 2008:
1. Glycosuria
2. Ketonuria
3. Other chronic illness or chromosomal abnormality or syndrome eg. Prader-Willi, Turners syndrome, hypothyroidism
4. Renal insufficiency
5. Hepatic dysfunction (raised ALT >2 SDS above mean)
6. Chronic diarrhoea
7. Previous episode lactic acidosis
Recruitment start date
01/01/2005
Recruitment end date
30/06/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Manchester Academic Health Sciences Centre
Manchester
M13 9WL
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Central Manchester and Manchester Children's University Hospitals NHS Trust (UK) - NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Child Growth Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23175691
Publication citations
-
Results
Kendall D, Vail A, Amin R, Barrett T, Dimitri P, Ivison F, Kibirige M, Mathew V, Matyka K, McGovern A, Stirling H, Tetlow L, Wales J, Wright N, Clayton P, Hall C, Metformin in obese children and adolescents: the MOCA trial., J. Clin. Endocrinol. Metab., 2013, 98, 1, 322-329, doi: 10.1210/jc.2012-2710.