'Eat Smart for Success': Investigating the use of pharmacotherapy in adolescents for weight loss maintenance: The role of appetite

ISRCTN	ISRCTN08063839
DOI	https://doi.org/10.1186/ISRCTN08063839
Protocol serial number	N/A
Sponsor	Royal Children's Hospital (Australia)
Funders	Australian Paediatric Endocrine Care (APEC) Research Grant (Pfizer) (Australia) - (ref: E/09) (contact: trudy.snape@pfizer.com), Royal Children's Hospital (Australia)

Submission date: 07/06/2010
Registration date: 05/11/2010
Last edited: 15/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jennifer Batch
Scientific

Department of Endocrinology and Diabetes
4th Floor, Coles Building
Herston Rd
Herston, Qld
4029
Australia

Phone	+61 (0)7 3636 3767
Email	jenny_batch@health.qld.gov.au

Study information

Primary study design	Interventional
Study design	Single centre randomised placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Investigating the use of pharmacotherapy in adolescents for weight loss maintenance: The role of appetite: A randomised, placebo controlled trial
Study objectives	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(s)	Approved by the Human Research Ethics Committee (HREC) of the Royal Children's Hospital (ref: HREC/10/QRCH/53)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Metformin
Primary outcome measure(s)	BMI (pre and post intervention)
Key secondary outcome measure(s)	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.
Completion date	30/06/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	48
Key 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
Key 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
Date of first enrolment	01/07/2010
Date of final enrolment	30/06/2014

Locations

Countries of recruitment

Australia

Study participating centre

Department of Endocrinology and Diabetes

Herston, Qld
4029
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes