Prepubertal insulin sensitisation in girls with a combined history of low birthweight and precocious pubarche
| ISRCTN | ISRCTN84749320 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84749320 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/08/2005
- Registration date
- 05/10/2005
- Last edited
- 11/07/2008
- 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 Ibanez
Scientific
Scientific
Hospital Sant Joan de Deu
University of Barcelona
Esplugues, Barcelona
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 | P&M |
| Study objectives | Insulin sensitisation delays pubertal onset in low birthweight girls with precocious pubarche. Please note that as of 11/07/2008, this trial has been updated. All updates can be found in the relevant field under the update date. |
| Ethics approval(s) | Added 11/07/2008: Ethics approval received from the Comité de Recerca, Hospital Sant Joan de Déu, University of Barcelona (Spain) on the 11th April 2001. The original protocol was also approved by the Agencia Española del Medicamento (ref: 01-0056, code HSJD-LIT-01). An amendment was presented in January 2008; the absence of reply from the administration implies approval. |
| Health condition(s) or problem(s) studied | Precocious pubarche |
| Intervention | Randomised subgroups: 1. Metformin 425 mg/day 2. Untreated Added as of 11/07/2008: Cross-over of therapy from year 6 of follow-up. All patients have been off therapy from year 5 (July 2007) to year 6. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure | Onset of puberty, measured at baseline and every 6 months (timepoints added 11/07/2008) |
| Secondary outcome measures | 1. Menarche, measured baseline and every 6 months. All untreated girls are already menarcheal, 14 of 19 treated girls are mernarcheal. 2. Final height, measured end of the 6th year Timepoints added 11/07/2008 |
| Overall study start date | 10/10/2002 |
| Completion date | 10/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Female |
| Target number of participants | 38 |
| Key inclusion criteria | Girls with a combined history of low birthweight (less than 1.5 standard deviation score [SDS]) and precocious pubarche (appearance of pubic hair before age 8) |
| Key exclusion criteria | 1. Congenital adrenal hyperplasia 2. Diabetes mellitus 3. Thyroid dysfunction |
| Date of first enrolment | 10/10/2002 |
| Date of final enrolment | 10/10/2007 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Sant Joan de Deu
Esplugues, Barcelona
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 Deu, 2
Esplugues, Barcelona
08950
Spain
| Website | http://www.hsjd.org |
|---|---|
"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 | 01/09/2004 | Yes | No |
