Insulin sensitisation to delay pubertal progression in girls: a pilot study in small-for-gestational-age (SGA) girls with an early-normal onset of puberty
| ISRCTN | ISRCTN06805028 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06805028 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/08/2005
- Registration date
- 05/10/2005
- Last edited
- 11/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Lourdes Ibañez
Scientific
Scientific
Hospital Sant Joan de Déu
University of Barcelona
Esplugues
08950
Spain
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Metformin-Puberty |
| Study objectives | Modulation of insulin-signalling contributes to variation in the tempo of pubertal progression in girls. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Advanced and progressive puberty in low-birthweight girls, resulting in final height below target |
| Intervention | Insulin sensitisation: metformin 850 mg/day versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure | 1. Menarche 2. Final height |
| Secondary outcome measures | 1. Fasting insulin 2. IGF-I |
| Overall study start date | 20/10/2002 |
| Completion date | 25/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Female |
| Target number of participants | 22 |
| Key inclusion criteria | 1. Birthweight for gestational age below -1.5 standard deviation (SD) 2. Onset of breast development (Tanner stage 2, B2) between age 8-9 years and <12 months before study start 3. Height SD score (SDS) at enrollment at least 1 SD above mid-parental height 4. Height velocity >6 cm/year 5. Progressive puberty, as assessed by pelvic ultrasonography and by gonadotropin and steroid responses to gonadotropin releasing hormone (GnRH) agonist stimulation |
| Key exclusion criteria | A family or personal history of diabetes mellitus; a history of precocious pubarche; evidence for thyroid dysfunction, Cushing syndrome, hyperprolactinemia or glucose intolerance; medication known to affect gonadal function or carbohydrate metabolism. |
| Date of first enrolment | 20/10/2002 |
| Date of final enrolment | 25/06/2006 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Sant Joan de Déu
Esplugues
08950
Spain
08950
Spain
Sponsor information
Hospital Sant Joan de Deu (Spain)
Hospital/treatment centre
Hospital/treatment centre
University of Barcelona
Passeig de Sant Joan de Déu, 2
Esplugues
08950
Spain
"ROR" |
https://ror.org/001jx2139 |
|---|
Funders
Funder type
Hospital/treatment centre
Hospital Sant Joan de Déu (Spain)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2006 | Yes | No | |
| Results article | results | 01/09/2007 | Yes | No |
