The North European Small for Gestational Age Study (NESGAS) found that SGA children who were more sensitive to insulin grew better when they received Growth Hormone treatment. We think that giving Metformin to SGA children to make them more sensitive to insulin may make them respond better to Growth Hormone treatment. Growth Hormone improves the growth by producing a growth promoting hormone called Insulin like Growth Factor-1(IGF-1).
The aim of this Mechanistic study is to determine if giving Metformin to children who are treated with Growth Hormone because they were born Small for Gestational Age (SGA) and remained short for their age, will show a better IGF-1 response to Growth Hormone treatment. We plan to recruit 24 children starting GH treatment and these will be from 4 paediatric endocrine units in Denmark, Ireland and the UK.
Drug being tested
Metformin is used to treat people with type 2 diabetes as it makes them more sensitive to insulin, a hormone which regulates blood glucose levels. We will measure the levels of Insulin like growth factor-1 in blood to measure the children’s response to Growth Hormone treatment, it will also give us a clue on the long-term effects of Metformin on growth.
Short SGA children between age 4 -10 years who are also, prepubertal and naïve to Growth Hormone.
Children will be randomised in a 1:1 ratio to Metformin or placebo for 6 months and followed up for another 6 months.
- They will receive GH treatment for the entire duration of the study (12 months).
- They will undergo an oral glucose tolerance test (OGTT) and DEXA scans to determine glucose metabolism and body fat mass at baseline and 6 months visits.
- They will have 1-3 monthly measurements of height, weight and skinfold thickness, and blood tests for hormones and safety measures.
Primary outcome will be the area under the curve of IGF- 1 levels measured at 0, 1, 3 and 6 months.
Secondary outcomes will include changes in insulin sensitivity, height, body fat mass and safety measures at 6 and 12 months.
Julie Harris SGAMetformin@paed.cam.ac.uk