'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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Endocrinology and Diabetes
4th Floor, Coles Building
Herston Rd
Herston, Qld
4029
Australia
| Phone | +61 (0)7 3636 3767 |
|---|---|
| jenny_batch@health.qld.gov.au |
Study information
| Study design | Single centre randomised placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact information below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/07/2010 |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
4029
Australia
Sponsor information
Royal Children's Hospital (Australia)
Hospital/treatment centre
Hospital/treatment centre
Herston Road
Herston, Queensland
4104
Australia
"ROR" |
https://ror.org/02rktxt32 |
|---|
Funders
Funder type
Industry
Australian Paediatric Endocrine Care (APEC) Research Grant (Pfizer) (Australia) - (ref: E/09) (contact: trudy.snape@pfizer.com)
No information available
Royal Children's Hospital (Australia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
