Adolescent Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
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 tabl
Sponsors
Royal Children's Hospital (Australia)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI (pre and post intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Australia
Outcome results
None listed