Addition of metformin to growth hormone for short children born small for gestational age
| ISRCTN | ISRCTN19548431 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19548431 |
| Clinical Trials Information System (CTIS) | 2009-016246-12 |
| Protocol serial number | 2009-016246-12 |
| Sponsor | Hospital Sant Joan de Deu (Spain) |
| Funder | Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref: TRA-131) |
- Submission date
- 12/02/2010
- Registration date
- 27/05/2010
- Last edited
- 27/05/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Dr Paula Casano
Scientific
Scientific
Hospital Sant Joan de Deu
University of Barcelona
Esplugues
Barcelona
08950
Spain
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double-blind two-armed clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of metformin on cardiovascular risk factors in prepubertal children born small for gestational age without postnatal catch-up growth, currently treated with growth hormone: a prospective randomised clinical trial |
| Study acronym | GH-MET |
| Study objectives | In prepubertal small for gestational age (SGA) children treated with growth hormone (GH), the addition of metformin will have beneficial effects on cardiovascular risk markers and body composition. |
| Ethics approval(s) | Ethical Committee of Hospital Sant Joan de Deu, University of Barcelona, approved on the 2nd February 2010 |
| Health condition(s) or problem(s) studied | Short children born small for gestational age |
| Intervention | Administration of metformin (425 mg/d) or placebo per oral once daily (at night) over 12 months. Total duration of follow-up is 18 months. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure(s) |
Insulin sensitivity (homeostatic model assessment [HOMA]), fasting insulin and visceral fat. An increase in insulin sensitivity (estimated using the HOMA method) equal or greater than 30%, accompanied by a decrease of 10% in visceral fat mass, will be considered a positive and discriminative response. |
| Key secondary outcome measure(s) |
1. Pubertal onset (girls) |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 10 Years |
| Sex | All |
| Target sample size at registration | 64 |
| Key inclusion criteria | 1. Prepubertal boys and girls between 7- 10 years old 2. SGA: weight less than or equal to -2 SD for gestational age and gender 3. Full-term pregnancy (gestational age between 37 - 42 weeks) 4. Caucasian origin 5. Prepubertal (Tanner I) 6. GH treatment during the previous 1 - 3 years and currently on treatment at the time of the study 7. Positive response to GH treatment with a 1 SD increase in height velocity |
| Key exclusion criteria | 1. Known causes of SGA: congenital infections, genetic syndromes 2. Drug and/or alcohol consumption 3. During the study: liver or kidney disorders or oncological disease 4. Thyroid hormone disorders 5. Obesity (body mass index [BMI] greater than or equal to + 2SD for age), glucose intolerance or type 2 diabetes 6. Treatment with glucocorticoids, sex hormones or drugs that could affect glucose tolerance 7. Infectious or inflammatory symptoms in the 15 days prior to sample collection |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 01/10/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Sant Joan de Deu
Barcelona
08950
Spain
08950
Spain
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 |
