Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PIC-72-10
Study information
Scientific title
PharmacoKinetics of Metformin at age 9
Acronym
MPK
Study hypothesis
To ascertain whether the pharmacokinetic parameters after oral metformin administration in young children are comparable to those in adults
Ethics approval
Review Board Hospital Sant Joan de Deu, apporved on 10th November 2010
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
03/03/2011
Overall trial end date
12/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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).
Participant type
Patient
Age group
Child
Gender
Female
Target number of participants
6
Participant 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.
Recruitment start date
03/03/2011
Recruitment end date
12/03/2011
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Sant Joan de Deu, University of Barcelona
Esplugues, Barcelona
08950
Spain
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital Sant Joan de Déu, University of Barcelona (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21973270
Publication citations
-
Results
Sánchez-Infantes D, Díaz M, López-Bermejo A, Marcos MV, de Zegher F, Ibáñez L, Pharmacokinetics of metformin in girls aged 9 years., Clin Pharmacokinet, 2011, 50, 11, 735-738, doi: 10.2165/11593970-000000000-00000.