Metformin PharmacoKinetics in young girls
| ISRCTN | ISRCTN49334271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49334271 |
| Secondary identifying numbers | PIC-72-10 |
- Submission date
- 03/03/2011
- Registration date
- 15/03/2011
- Last edited
- 14/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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 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) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | PharmacoKinetics of Metformin at age 9 |
| Study acronym | MPK |
| Study objectives | To ascertain whether the pharmacokinetic parameters after oral metformin administration in young children are comparable to those in adults |
| Ethics approval(s) | Review Board Hospital Sant Joan de Deu, apporved on 10th November 2010 |
| Health condition(s) or problem(s) studied | Advanced puberty |
| Intervention | The patients were sampled after being admitted to the hospital,every 45 minutes for 3 hours and then 4, 6, 8, 10 and 12 hours after metformin intake, 850 mg/d. The girls were started on metformin at a mean age of 9 years. |
| Intervention type | Other |
| Primary outcome measure | 1. Height velocity: according to local reference curves: Ferrández-Longás A, Mayayo E, Labarta JI, Bagué L, Puga B, Rueda C, Ruiz-Echarri M, Labena C. Estudio longitudinal de crecimiento y desarrollo. Centro Andrea Prader. Zaragoza 1980-2002. In ERGON, ed. Patrones de crecimiento y desarrollo en España. Atlas de gráficas y tablas., pp 61-115. Madrid: 2004 2. Pubertal status: according to Tanner standards (Marshall WA, Tanner JM. Variations in the pattern of pubertal changes in girls. Arch Dis Child 1969; 44:291-303) |
| Secondary outcome measures | 1. Bone age: according to Greulich & Pyle 2. Uterine and ovarian size: as measured by ultrasound and according to: Griffin IJ, Cole TJ, Duncan KA, Hollman AS, Donaldson MDC. Pelvic ultrasound measurements in normal girls. Acta Paediatr 1995; 84:536-543 |
| Overall study start date | 03/03/2011 |
| Completion date | 12/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Female |
| Target number of participants | 6 |
| Key inclusion criteria | The study population consisted of 6 non-obese, Caucasian girls receiving metformin (850 mg/d at dinner time) after a history of low-birthweight (Z-score ¡Ü -1.5 for gestational age) and early-normal puberty (onset of Tanner breast stage 2 at age 8 yr; increase of uterine and ovarian size by ultrasound; pubertal gonadotropin response to GnRH agonist). |
| Key exclusion criteria | 1. A family or personal history of diabetes mellitus 2. A history of precocious pubarche or the presence of other signs of androgen excess 3. Evidence for thyroid dysfunction or glucose intolerance 4. Intake of medications known to affect gonadal function or carbohydrate metabolism. |
| Date of first enrolment | 03/03/2011 |
| Date of final enrolment | 12/03/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Sant Joan de Deu, University of Barcelona
Esplugues, Barcelona
08950
Spain
08950
Spain
Sponsor information
Hospital Sant Joan de Déu, University of Barcelona (Spain)
Hospital/treatment centre
Hospital/treatment centre
Hospital Sant Joan de Deu, Univeristy of Barcelona
c/o Lourdes Ibañez
Esplugues, Barcelona
08950
Spain
"ROR" |
https://ror.org/001jx2139 |
|---|
Funders
Funder type
Hospital/treatment centre
Hospital Sant Joan de Déu, University of Barcelona (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 | 01/11/2011 | Yes | No |
