Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/03/2011
Date assigned
15/03/2011
Last edited
14/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lourdes Ibañez

ORCID ID

Contact details

Hospital Sant Joan de Deu
University of Barcelona
Esplugues
Barcelona
08950
Spain

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 measures

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

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

Sponsor information

Organisation

Hospital Sant Joan de Déu, University of Barcelona (Spain)

Sponsor details

Hospital Sant Joan de Deu
Univeristy of Barcelona
c/o Lourdes Ibañez
Esplugues
Barcelona
08950
Spain

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21973270

Publication citations

  1. 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.

Additional files

Editorial Notes