Metformin PharmacoKinetics in young girls

ISRCTN	ISRCTN49334271
DOI	https://doi.org/10.1186/ISRCTN49334271
Protocol serial number	PIC-72-10
Sponsor	Hospital Sant Joan de Déu, University of Barcelona (Spain)
Funder	Hospital Sant Joan de Déu, University of Barcelona (Spain)

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

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
Study type	Participant 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(s)	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)
Key secondary outcome measure(s)	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
Completion date	12/03/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Female
Target sample size at registration	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

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	01/11/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes