Prepubertal insulin sensitisation in girls with a combined history of low birthweight and precocious pubarche
| ISRCTN | ISRCTN84749320 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84749320 |
| Protocol serial number | N/A |
| Sponsor | Hospital Sant Joan de Deu (Spain) |
| Funder | Hospital Sant Joan de Déu (Spain) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure(s) |
Onset of puberty, measured at baseline and every 6 months (timepoints added 11/07/2008) |
| Key secondary outcome measure(s) |
1. Menarche, measured baseline and every 6 months. All untreated girls are already menarcheal, 14 of 19 treated girls are mernarcheal. |
| Completion date | 10/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Female |
| Target sample size at registration | 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
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? |
|---|---|---|---|---|---|
| Results article | Results | 01/09/2004 | Yes | No |
