Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/06/2010
Date assigned
05/11/2010
Last edited
15/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Royal Children's Hospital (Australia)

Sponsor details

Herston Road
Herston
Queensland
4104
Australia

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes