Plain English Summary
Not provided at time of registration
Trial website
http://www2.som.uq.edu.au/som/Research/ResearchCentres/cnrc/Pages/CNRCHome.aspx
Contact information
Type
Scientific
Primary contact
Prof Jennifer Batch
ORCID ID
Contact details
Department of Endocrinology and Diabetes
4th Floor
Coles Building
Herston Rd
Herston
Qld
4029
Australia
+61 (0)7 3636 3767
jenny_batch@health.qld.gov.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Investigating the use of pharmacotherapy in adolescents for weight loss maintenance: The role of appetite: A randomised, placebo controlled trial
Acronym
Study hypothesis
1. Metformin will prevent weight regain in obese adolescents after a period of weight loss
2. Metformin improves satiety such that the drive to eat and food intake are reduced
3. Metformin causes a decrease in circulating orexogenic hormones (Ghrelin) and an increase in anorexigenic hormones (Glucagon-Like Peptide 1 [GLP-1], pancreatic polypeptide [PP] and peptide YY [PYY]) both acutely and after chronic administration
4. Food preferences and the drive to eat differ between obese adolescents and their healthy weight peers
Please note that as of 15/05/2013, the anticipated end date for this trial was updated from 30/06/2013 to 30/06/2014.
Ethics approval
Approved by the Human Research Ethics Committee (HREC) of the Royal Children's Hospital (ref: HREC/10/QRCH/53)
Study design
Single centre randomised placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact information below to request a patient information sheet
Condition
Adolescent Obesity
Intervention
Obese adolescents (12-18 years with BMI z-score >95th Centile for age) will be randomised to receive metformin or placebo orally.
Starting dose will be 500mg (1 tablet) bd, increasing to 500mg (1 tablet) every morning/mane and 1g (2 tablets) every evening/nocte at 2 weeks, increasing again to 1g (2 tablets) bd at 1 month for the remainder of the trial
The total length of the intervention will be 6 months.
Medication is to be taken with meals and doses where participants come to the hospital for testing, will be supervised. Complicance overall will be monitored by the study pharmacist by pill counting.
All subjects will receive lifestyle intervention - structured dietary restriction and general advice on increasing physical activity
Intervention type
Drug
Phase
Phase IV
Drug names
Metformin
Primary outcome measure
BMI (pre and post intervention)
Secondary outcome measures
1. Subjective appetite sensations using a novel Electronic appetite Rating system (EARS), immediately before and then hourly for 4 hours after a fixed-energy breakfast. Measured at baseline, day 1, week 2, week 4, then monthly. This is a validated technique of measuring appetite which has been used in appetite studies involving obese children.
2. Food preferences will be measured using a novel 'liking and wanting' (L&W) experimental procedure. Measured at baseline, day 1, week 2, week 4, then monthly. This method has been validated in several studies. The L&W procedure is sensitive to detect changes in nutrient and taste preferences.
3. We will measure fasting gastrointestinal hormones (at baseline, day 28, 2mo and 6mo) to identify potential biomarkers which could explain any differences in appetite responses between the two groups. These will be correlated with fasting and postprandial subjective appetite sensations.
4. In a subset of patients (10 in each group), we will measure the gastrointestinal hormones and subjective sensations of appetite, pre- and postprandially (by insertion of an intravenous cannula) and pre and post dosing with metformin. These measurements will be taken at baseline, each metformin dose increment (d1, wk2, wk4), 2mo and 6mo.
Overall trial start date
01/07/2010
Overall trial end date
30/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 12-18 years
2. BMI >95th centile for age and gender
3. Pubertal stage ≥3
4. Ability for parent and child to read and understand written instructions in English; parents able to give informed written consent in English; adolescent able to give verbal assent
5. Successfully completed a 6 month lifestyle intervention without a gain in BMI z-score
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
48
Participant exclusion criteria
1. Those with renal disorders, diabetes, diagnosed psychological disorders
2. Those taking stimulants or psychotropic medication or drugs known to alter metabolism including insulin sensitisers, glucocorticoids, thyroxine, other weight loss medications
3. Those taking any drugs known to be contraindicated with metformin therapy
4. Known adverse reactions to metformin
5. Pregnancy
Recruitment start date
01/07/2010
Recruitment end date
30/06/2014
Locations
Countries of recruitment
Australia
Trial participating centre
Department of Endocrinology and Diabetes
Herston, Qld
4029
Australia
Funders
Funder type
Industry
Funder name
Australian Paediatric Endocrine Care (APEC) Research Grant (Pfizer) (Australia) - (ref: E/09) (contact: trudy.snape@pfizer.com)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Royal Children's Hospital (Australia)
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